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Obstetrics and Gynecology Jun 2021To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone.
DATA SOURCES
Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020).
METHODS OF STUDY SELECTION
Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation.
TABULATION, INTEGRATION, AND RESULTS
Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient.
CONCLUSION
In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42020167406.
Topics: Ambulatory Care; Catheters; Cervical Ripening; Cesarean Section; Dilatation; Dinoprostone; Female; Hospitalization; Humans; Labor, Induced; Obstetric Labor Complications; Oxytocics; Pregnancy
PubMed: 33752219
DOI: 10.1097/AOG.0000000000004382 -
The European Journal of Contraception &... Oct 2021To systematically and meta-analytically investigate the efficacy and safety of vaginal dinoprostone versus placebo in pain relief during intrauterine device (IUD)... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To systematically and meta-analytically investigate the efficacy and safety of vaginal dinoprostone versus placebo in pain relief during intrauterine device (IUD) insertion.
METHODS
PubMed, Scopus, Web of Science, and Cochrane Library were screened till 1 October 2020. Only randomised placebo-controlled studies were included and assessed for risk of bias. Main outcomes included IUD insertion related pain, patient satisfaction, provider ease of IUD insertion, and side effects. Pooled outcomes were summarised as standardised mean difference (SMD), weighted mean difference (WMD), or risk ratio (RR) with 95% confidence interval (95% CI).
RESULTS
Five studies were included, comprising 862 patients; equally 431 patients received vaginal dinoprostone and placebo. All studies showed an overall low risk of bias. When compared to placebo, dinoprostone significantly correlated with decreased pain at tenaculum placement (SMD = -0.79, 95% CI [-1.43, -0.16], = 0.01), decreased pain at uterine sounding (SMD = -0.88, 95% CI [-1.54, -0.22], = 0.009), decreased pain at IUD insertion (SMD = -1.18, 95% CI [-1.74, -0.61], < 0.001), decreased need for additional analgesia (RR = 0.34, 95% CI [0.22, 0.53], < 0.001), increased patient satisfaction (SMD = 1.41, 95% CI [0.62, 2.20], < 0.001), and increased provider ease of IUD insertion (SMD = -1.17, 95% CI [-1.62, -0.73], < 0.001). Fever was statistically significantly higher in dinoprostone versus placebo group (RR = 3.73, 95% CI [1.47, 9.44], = 0.006). All other side effects-including nausea, vomiting, shivering, diarrhoea, abdominal cramps, vasovagal attack, uterine perforation, and postprocedural bleeding-did not substantially differ between both groups.
CONCLUSIONS
This first ever meta-analysis advocates that dinoprostone compared with placebo is safe, effective, and yields favourable analgesic outcomes during IUD insertion.
Topics: Dinoprostone; Female; Humans; Intrauterine Devices; Oxytocics; Pain; Pain Measurement; Randomized Controlled Trials as Topic
PubMed: 33691549
DOI: 10.1080/13625187.2021.1891411 -
BJOG : An International Journal of... Jun 2021There are uncertainties about the benefit of routine cervical preparation and/or cervical dilatation before outpatient hysteroscopy. (Meta-Analysis)
Meta-Analysis
BACKGROUND
There are uncertainties about the benefit of routine cervical preparation and/or cervical dilatation before outpatient hysteroscopy.
OBJECTIVE
To determine if cervical preparation and/or routine mechanical dilatation reduces pain during outpatient hysteroscopy.
SEARCH STRATEGY
MEDLINE, EMBASE, CINAHL and CENTRAL were searched on 19 October 2020, using keywords 'hysteroscopy', 'cervical preparation', 'cervical ripening', 'cervical dilatation', 'outpatient', 'office' and/or 'ambulatory' and associated medical subject headings.
SELECTION CRITERIA
Randomised controlled trials investigating the benefit of cervical preparation and/or cervical dilatation on pain in women undergoing outpatient hysteroscopy were included.
DATA COLLECTION AND ANALYSIS
Two independent reviewers selected eligible trials and extracted data on pain, feasibility, adverse events and satisfaction/acceptability for meta-analysis.
MAIN RESULTS
The literature search yielded 807 records, of which 24 were included for review and 19 provided data for meta-analysis. No trials investigated the role of routine mechanical cervical dilatation. Cervical preparation significantly reduced pain during outpatient hysteroscopy; standard mean difference (SMD) -0.67, 95% confidence interval (CI) -1.05 to -0.29. Feasibility also improved as priming provided significantly easier hysteroscopic entry (SMD 0.89, 95% CI 0.32-1.46), greater cervical dilatation (SMD 0.81, 95% CI 0.08-1.53) and shorter procedural times (SMD -0.51, 95% CI -0.88 to -0.13). Cervical preparation, however, incurred significantly more adverse effects, mainly comprising genital tract bleeding, abdominal pain and gastrointestinal symptoms (odds ratio 2.94, 95% CI 1.58-5.47). There were limited data regarding satisfaction, acceptability and complications.
CONCLUSIONS
Cervical preparation reduces pain and improves feasibility associated with outpatient hysteroscopy but increases the risk of adverse effects.
TWEETABLE ABSTRACT
Cervical preparation before outpatient hysteroscopy reduces pain, enhances feasibility but increases adverse effects.
Topics: Abdominal Pain; Ambulatory Surgical Procedures; Cervix Uteri; Dilatation; Female; Humans; Hysteroscopy; Operative Time; Pain, Postoperative; Postoperative Hemorrhage; Preoperative Care
PubMed: 33219606
DOI: 10.1111/1471-0528.16604 -
The Cochrane Database of Systematic... Aug 2020The setting in which induction of labour takes place (home or inpatient) is likely to have implications for safety, women's experiences and costs. Home induction may be... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
The setting in which induction of labour takes place (home or inpatient) is likely to have implications for safety, women's experiences and costs. Home induction may be started at home with the subsequent active phase of labour happening either at home or in a healthcare facility (hospital, birth centre, midwifery-led unit). More commonly, home induction starts in a healthcare facility, then the woman goes home to await the start of labour. Inpatient induction takes place in a healthcare facility where the woman stays while awaiting the start of labour.
OBJECTIVES
To assess the effects on neonatal and maternal outcomes of third trimester home induction of labour compared with inpatient induction using the same method of induction.
SEARCH METHODS
For this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (31 January 2020)), and reference lists of retrieved studies.
SELECTION CRITERIA
Published and unpublished randomised controlled trials (RCTs) in which home and inpatient settings for induction have been compared. We included conference abstracts but excluded quasi-randomised trials and cross-over studies.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently. GRADE assessments were checked by a third review author.
MAIN RESULTS
We included seven RCTs, six of which provided data on 1610 women and their babies. Studies were undertaken between 1998 and 2015, and all were in high- or upper-middle income countries. Most women were induced for post dates. Three studies reported government funding, one reported no funding and three did not report on their funding source. Most GRADE assessments gave very low-certainty evidence, downgrading mostly for high risk of bias and serious imprecision. 1. Home compared to inpatient induction with vaginal prostaglandin E (PGE) (two RCTs, 1028 women and babies; 1022 providing data). Although women's satisfaction may be slightly better in home settings, the evidence is very uncertain (mean difference (MD) 0.16, 95% confidence interval (CI) -0.02 to 0.34, 1 study, 399 women), very low-certainty evidence. There may be little or no difference between home and inpatient induction for other primary outcomes, with all evidence being very low certainty: - spontaneous vaginal birth (average risk ratio (RR) [aRR] 0.91, 95% CI 0.69 to 1.21, 2 studies, 1022 women, random-effects method); - uterine hyperstimulation (RR 1.19, 95% CI 0.40 to 3.50, 1 study, 821 women); - caesarean birth (RR 1.01, 95% CI 0.81 to 1.28, 2 studies, 1022 women); - neonatal infection (RR 1.29, 95% CI 0.59 to 2.82, 1 study, 821 babies); - admission to neonatal intensive care unit (NICU) (RR 1.20, 95% CI 0.50 to 2.90, 2 studies, 1022 babies). Studies did not report serious neonatal morbidity or mortality. 2. Home compared to inpatient induction with controlled release PGE (one RCT, 299 women and babies providing data). There was no information on whether the questionnaire on women's satisfaction with care used a validated instrument, but the findings presented showed no overall difference in scores. We found little or no difference between the groups for other primary outcomes, all also being very low-certainty evidence: - spontaneous vaginal birth (RR 0.94, 95% CI 0.77 to 1.14, 1 study, 299 women); - uterine hyperstimulation (RR 1.01, 95% CI 0.51 to 1.98, 1 study, 299 women); - caesarean births (RR 0.95, 95% CI 0.64 to 1.42, 1 study, 299 women); - admission to NICU (RR 1.38, 0.57 to 3.34, 1 study, 299 babies). The study did not report on neonatal infection nor serious neonatal morbidity or mortality. 3. Home compared to inpatient induction with balloon or Foley catheter (four RCTs; three studies, 289 women and babies providing data). It was again unclear whether questionnaires reporting women's experiences/satisfaction with care were validated instruments, with one study (48 women, 69% response rate) finding women were similarly satisfied. Home inductions may reduce the number of caesarean births, but the data are also compatible with a slight increase and are of very low-certainty (RR 0.64, 95% CI 0.41 to 1.01, 2 studies, 159 women). There was little or no difference between the groups for other primary outcomes with all being very low-certainty evidence: - spontaneous vaginal birth (RR 1.04, 95% CI 0.54 to 1.98, 1 study, 48 women): - uterine hyperstimulation (RR 0.45, 95% CI 0.03 to 6.79, 1 study, 48 women); - admission to NICU (RR 0.37, 95% CI 0.07 to 1.86, 2 studies, 159 babies). There were no serious neonatal infections nor serious neonatal morbidity or mortality in the one study (involving 48 babies) assessing these outcomes.
AUTHORS' CONCLUSIONS
Data on the effectiveness, safety and women's experiences of home versus inpatient induction of labour are limited and of very low-certainty. Given that serious adverse events are likely to be extremely rare, the safety data are more likely to come from very large observational cohort studies rather than relatively small RCTs.
Topics: Ambulatory Care; Catheterization; Cervical Ripening; Cesarean Section; Delayed-Action Preparations; Dinoprostone; Female; Hospitalization; Humans; Infant, Newborn; Labor, Induced; Length of Stay; Oxytocics; Patient Safety; Patient Satisfaction; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic
PubMed: 32852803
DOI: 10.1002/14651858.CD007372.pub4 -
European Journal of Obstetrics,... Sep 2020To investigate the outcome of pregnancies with small baby, including both small for gestational age (SGA) and late fetal growth restriction (FGR) fetuses, undergoing... (Meta-Analysis)
Meta-Analysis Review
Adverse intrapartum outcome in pregnancies complicated by small for gestational age and late fetal growth restriction undergoing induction of labor with Dinoprostone, Misoprostol or mechanical methods: A systematic review and meta-analysis.
OBJECTIVE
To investigate the outcome of pregnancies with small baby, including both small for gestational age (SGA) and late fetal growth restriction (FGR) fetuses, undergoing induction of labor (IOL) with Dinoprostone, Misoprostol or mechanical methods.
STUDY DESIGN
Medline, Embase and Cochrane databases were searched. Inclusion criteria were non-anomalous singleton pregnancies complicated by the presence of a small fetus, defined as a fetus with estimated fetal weight (EFW) or abdominal circumference (AC) <10th centile undergoing IOL from 34 weeks of gestation with vaginal Dinoprostone, vaginal misoprostol, or mechanical methods (including either Foley or Cook balloon catheters). The primary outcome was a composite measure of adverse intrapartum outcome. Secondary outcomes were the individual components of the primary outcome, perinatal mortality and morbidity. All the explored outcomes were reported in three different sub-groups of pregnancies complicated by a small fetus including: all small fetuses (defined as those with an EFW and/or AC <10th centile irrespective of fetal Doppler status), late FGR fetuses (defined as those with EFW and/or AC <3rd centile or AC/EFW <10th centile associated with abnormal cerebroplacental Dopplers) and SGA fetuses (defined as those with EFW and/or AC <10th but >3rd centile with normal cerebroplacental Dopplers). Quality assessment of each included study was performed using the Risk of Bias in Non-randomized Studies-of Interventions tool (ROBINS-I), while the GRADE methodology was used to assess the quality of the body of retrieved evidence. Meta-analyses of proportions and individual data random-effect logistic regression were used to analyze the data.
RESULTS
12 studies (1711 pregnancies) were included. In the overall population of small fetuses, composite adverse intra-partum outcome occurred in 21.2 % (95 % CI 10.0-34.9) of pregnancies induced with Dinoprostone, 18.0 % (95 % CI 6.9-32.5) of those with Misoprostol and 11.6 % (95 % CI 5.5-19.3) of those undergoing IOL with mechanical methods. Cesarean section (CS) for non-reassuring fetal status (NRFS) was required in 18.1 % (95 % CI 9.9-28.3) of pregnancies induced with Dinoprostone, 9.4 % (95 % CI 1.4-22.0) of those with Misoprostol and 8.1 % (95 % CI 5.0-11.6) of those undergoing mechanical induction. Likewise, uterine tachysystole, was recorded on CTG in 13.8 % (95 % CI 6.9-22.3) of cases induced with Dinoprostone, 7.5 % (95 % CI 2.1-15.4) of those with Misoprostol and 3.8 % (95 % CI 0-4.4) of those induced with mechanical methods. Composite adverse perinatal outcome following delivery complicated 2.9 % (95 % CI 0.5-6.7) newborns after IOL with Dinoprostone, 0.6 % (95 % CI 0-2.5) with Misoprostol and 0.7 % (95 % CI 0-7.1) with mechanical methods. In pregnancies complicated by late FGR, adverse intrapartum outcome occurred in 25.3 % (95 % CI 18.8-32.5) of women undergoing IOL with Dinoprostone, compared to 7.4 % (95 % CI 3.9-11.7) of those with mechanical methods, while CS for NRFS was performed in 23.8 % (95 % CI 17.3-30.9) and 6.2 % (95 % CI 2.8-10.5) of the cases, respectively. Finally, in SGA fetuses, composite adverse intrapartum outcome complicated 8.4 % (95 % CI 4.6-13.0) of pregnancies induced with Dinoprostone, 18.6 % (95 % CI 13.1-25.2) of those with Misoprostol and 8.7 (95 % CI 2.5-17.5) of those undergoing mechanical IOL, while CS for NRF was performed in 8.4 % (95 % CI 4.6-13.0) of women induced with Dinoprostone, 18.6 % (95 % CI 13.1-25.2) of those with Misoprostol and 8.7 % (95 % CI 2.5-17.5) of those undergoing mechanical induction. Overall, the quality of the included studies was low and was downgraded due to considerable clinical and statistical heterogeneity.
CONCLUSIONS
There is limited evidence on the optimal type of IOL in pregnancies with small fetuses. Mechanical methods seem to be associated with a lower occurrence of adverse intrapartum outcomes, but a direct comparison between different techniques could not be performed.
Topics: Cesarean Section; Dinoprostone; Female; Fetal Growth Retardation; Gestational Age; Humans; Infant, Newborn; Infant, Small for Gestational Age; Labor, Induced; Misoprostol; Pregnancy; Ultrasonography, Prenatal
PubMed: 32738675
DOI: 10.1016/j.ejogrb.2020.07.020 -
American Journal of Obstetrics and... Sep 2020Retained placenta affects 2% to 3.3% of all vaginal deliveries and is one of the leading causes of postpartum hemorrhage worldwide. Despite the prevalence of this... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Retained placenta affects 2% to 3.3% of all vaginal deliveries and is one of the leading causes of postpartum hemorrhage worldwide. Despite the prevalence of this condition, there is limited guidance on its management.
OBJECTIVE
A systematic review and meta-analysis were performed to evaluate the efficacy of pharmacologic interventions for the management of retained placenta.
STUDY DESIGN
PubMed, ClinicalTrials.gov, Cochrane Library, Web of Science, and Scopus were searched for full-text publications in English. Search terms included "retained placenta" AND "treatment" OR "therapy" OR "disease management" OR "Pitocin" OR "misoprostol" OR "Cytotec" OR "dinoprostone" OR "nitroglycerin" OR "carbetocin" OR "ergotamine," with no restriction on publication dates. Only randomized controlled trials were included. The primary outcome was the need for manual extraction of the placenta or dilation and curettage. Reviewers evaluated the quality of included articles using the Cochrane Collaboration's tool for assessing the risk of bias. Pooled risk ratios were estimated based on random- and fixed-effects analyses. Interstudy heterogeneity was considered when I≥50%.
RESULTS
The literature search identified 29 randomized controlled trials that met the inclusion criteria (2682 subjects). The most commonly used agent across the studies was oxytocin administered via umbilical vein injection; there was high heterogeneity among these studies (I=62%). Oxytocin was inferior to carbetocin (risk ratio, 1.61; 95% confidence interval, 1.03-2.52) and prostaglandins (risk ratio, 2.63; 95% confidence interval, 1.18-5.86) for the primary outcome. For oxytocin, prostaglandin agents, and nitroglycerin, there was a trend toward favoring the study drug for the primary outcome compared with control or placebo. Compared with placebo or control, estimated blood loss was lower if pharmacologic interventions were administered, with a mean difference of 121.5 mL (95% confidence interval, -185.7 to -52.3). There was no difference in postpartum hemorrhage or the need for blood transfusion between pharmacologic interventions and placebo or control.
CONCLUSION
Pooled estimates for oxytocin via umbilical vein injection, prostaglandin agents, and nitroglycerin performed favorably compared with placebo or control for the management of retained placenta. Carbetocin and prostaglandin agents were superior to oxytocin in reducing the need for manual extraction or dilation and curettage.
Topics: Female; Humans; Oxytocics; Perinatal Care; Placenta, Retained; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 32592695
DOI: 10.1016/j.ajog.2020.06.044 -
Medicine Nov 2018Successful labor induction depends on the cervical status at the time of induction. Currently, both a Foley catheter and a dinoprostone insert are used for effective... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Successful labor induction depends on the cervical status at the time of induction. Currently, both a Foley catheter and a dinoprostone insert are used for effective cervical ripening. This study compared the efficacy and safety of the intracervical Foley catheter and dinoprostone insert for cervical ripening to achieve successful labor induction.
METHODS
PubMed, Embase, and the Cochrane Library were searched from January 2000 to February 2017 for relevant articles. Only published randomized, controlled trials comparing the dinoprostone insert with the Foley catheter were included.
RESULTS
Eight trials including 1191 women who received the intracervical Foley catheter balloon and 1199 who received the dinoprostone insert were used for this study. There was no significant difference between the 2 groups regarding the induction-to-delivery (I-D) interval in a random effect model (mean difference, 0.71 hours; 95% confidence interval [CI], -2.50 to 3.91; P = .67). The highly significant heterogeneity (I = 97%) could be explained by the subgroup analysis of the type of Foley catheter and balloon volume. There was no significant difference between the 2 methods regarding the cesarean delivery rate (relative risk, 0.91; 95% CI, 0.78-1.07; P = .24), Apgar score, or side effects, including maternal infection rate, postpartum hemorrhage, and hyperstimulation. No obvious publication bias was found.
CONCLUSIONS
According to the cesarean delivery rate, the intracervical Foley catheter balloon was as efficient as the dinoprostone insert. A moderate balloon volume (30 mL) and higher dose of dinoprostone (≥6 mg) were related to shorter I-D intervals. Additionally, there was no significant difference between the two methods regarding maternal or neonatal safety.
Topics: Catheters; Cervical Ripening; Dinoprostone; Drug Delivery Systems; Female; Humans; Labor, Induced; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 30508911
DOI: 10.1097/MD.0000000000013251 -
Journal of Dermatological Science Apr 2018Primary hypertrophic osteoarthropathy (PHO), also known as pachydermoperiostosis is a rare genetic disease which predominantly affects skin, bone and soft connective... (Review)
Review
BACKGROUND
Primary hypertrophic osteoarthropathy (PHO), also known as pachydermoperiostosis is a rare genetic disease which predominantly affects skin, bone and soft connective tissue. It is characterized by the triad of pachydermia, digital clubbing and periostosis of long bones. Arthralgia or arthritis is also present in most of the cases. Genetic studies have identified the impaired PGE2 metabolism as a culprit for hypertrophic osteoarthropathy in PHO cases. We conducted a systematic review to examine the effectiveness of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), a PGE2 synthesis blocker to reduce the symptoms among PHO patients.
METHODS
We searched the evidence in five databases; Cochrane Library, CINAHL, EMBASE, MEDLINE, and PubMed. We reported the evidence using narrative synthesis.
RESULTS
Out of 238 identified studies, we selected 26 for the synthesis. All were case reports which included a total of 54 patients. Among them, 39 patients were treated with at least one type of NSAIDs. Around 70% of the patients treated with NSAIDs had clinical improvement for their symptoms, mostly arthritis or arthralgia symptoms.
CONCLUSION
NSAIDs were effective in improving arthralgia or arthritis symptoms in majority of the PHO patients. Therefore, we recommend the use of NSAIDs in PHO patients to treat arthralgia or arthritis.
Topics: Cyclooxygenase Inhibitors; Dinoprostone; Humans; Osteoarthropathy, Primary Hypertrophic; Rare Diseases; Treatment Outcome
PubMed: 29305259
DOI: 10.1016/j.jdermsci.2017.12.012 -
European Journal of Obstetrics,... Nov 2017Induction of labour is one of the most frequently applied obstetrical interventions globally. Many studies have compared the use of balloon catheters with... (Review)
Review
Induction of labour is one of the most frequently applied obstetrical interventions globally. Many studies have compared the use of balloon catheters with pharmacological agents. Although the safety of the balloon catheter is often mentioned, little has been written about the total spectrum of maternal and fetal morbidity associated with induction of labour using a balloon catheter. We evaluated the safety of labour induction with a transcervical balloon catheter by conducting a literature review with pooled risk assessments of the maternal, fetal and neonatal morbidity. We searched Medline, EMBASE and CINAHL as well as the Cochrane database using the Keywords 'induction of labour', 'cervical ripening', 'transcervical balloon', 'balloon catheter' and 'Foley balloon'. We did not use language or date restrictions. Randomized and quasi-randomized controlled trials as well as observational studies that contained original data on occurrence of maternal, fetal or neonatal morbidity during induction of labour with the balloon catheter were included. Studies were excluded if the balloon catheter was used concurrently with oxytocin and concurrently or consecutively with misoprostol, dinoprostone or extra-amniotic saline infusion. Study selection and quality assessment was performed by two authors independently using a standardized critical appraisal instrument. Outcomes were reported as weighted mean rates. We detected 84 articles reporting on 13,791 women. The overall risk of developing intrapartum maternal infection was 11.3% (912 of 8079 women), 3.3% (151 of 4538 women) for postpartum maternal infection and 4.6% (203 of 4460 women) for neonatal infection. Uterine hypercontractility occurred in 2.7% (148 of 5439) of the women. Uterine rupture after previous caesarean section occurred in 1.9% of women (26 of 1373), while other major maternal complications had an occurrence rate of <1%. The risk for developing minor maternal complications was <2%. The risk of developing a non-reassuring fetal heart rate was 10.8% (793 of 7336 women), 10.1% (507 of 5008 women) for fetal distress and 14.0% (460 of 3295 women) for meconium stained liquor. Neonatal death occurred in 0.29% (6 of 2058) of the deliveries and NICU admission in 7.2% (650 of 9065 deliveries). This review shows that labour induction with a balloon catheter is a safe intervention, with intrapartum maternal infection being the only reasonable risk above 10%.
Topics: Case-Control Studies; Cervical Ripening; Female; Humans; Labor, Induced; Observational Studies as Topic; Obstetric Labor Complications; Postpartum Period; Pregnancy; Pregnancy Outcome; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Urinary Catheters
PubMed: 28963922
DOI: 10.1016/j.ejogrb.2017.09.014 -
The Cochrane Database of Systematic... Sep 2017Induction of labour is carried out for a variety of indications and using a range of methods. For women at low risk of pregnancy complications, some methods of induction... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Induction of labour is carried out for a variety of indications and using a range of methods. For women at low risk of pregnancy complications, some methods of induction of labour or cervical ripening may be suitable for use in outpatient settings.
OBJECTIVES
To examine pharmacological and mechanical interventions to induce labour or ripen the cervix in outpatient settings in terms of effectiveness, maternal satisfaction, healthcare costs and, where information is available, safety.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised controlled trials examining outpatient cervical ripening or induction of labour with pharmacological agents or mechanical methods. Cluster trials were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed evidence using the GRADE approach.
MAIN RESULTS
This updated review included 34 studies of 11 different methods for labour induction with 5003 randomised women, where women received treatment at home or were sent home after initial treatment and monitoring in hospital.Studies examined vaginal and intracervical prostaglandin E₂ (PGE₂), vaginal and oral misoprostol, isosorbide mononitrate, mifepristone, oestrogens, amniotomy and acupuncture, compared with placebo, no treatment, or routine care. Trials generally recruited healthy women with a term pregnancy. The risk of bias was mostly low or unclear, however, in 16 trials blinding was unclear or not attempted. In general, limited data were available on the review's main and additional outcomes. Evidence was graded low to moderate quality. 1. Vaginal PGE₂ versus expectant management or placebo (5 studies)Fewer women in the vaginal PGE₂ group needed additional induction agents to induce labour, however, confidence intervals were wide (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.27 to 0.99; 150 women; 2 trials). There were no clear differences between groups in uterine hyperstimulation (with or without fetal heart rate (FHR) changes) (RR 3.76, 95% CI 0.64 to 22.24; 244 women; 4 studies; low-quality evidence), caesarean section (RR 0.80, 95% CI 0.49 to 1.31; 288 women; 4 studies; low-quality evidence), or admission to a neonatal intensive care unit (NICU) (RR 0.32, 95% CI 0.10 to 1.03; 230 infants; 3 studies; low-quality evidence).There was no information on vaginal birth within 24, 48 or 72 hours, length of hospital stay, use of emergency services or maternal or caregiver satisfaction. Serious maternal and neonatal morbidity or deaths were not reported. 2. Intracervical PGE₂ versus expectant management or placebo (7 studies) There was no clear difference between women receiving intracervical PGE₂ and no treatment or placebo in terms of need for additional induction agents (RR 0.98, 95% CI 0.74 to 1.32; 445 women; 3 studies), vaginal birth not achieved within 48 to 72 hours (RR 0.83, 95% CI 0.68 to 1.02; 43 women; 1 study; low-quality evidence), uterine hyperstimulation (with FHR changes) (RR 2.66, 95% CI 0.63 to 11.25; 488 women; 4 studies; low-quality evidence), caesarean section (RR 0.90, 95% CI 0.72 to 1.12; 674 women; 7 studies; moderate-quality evidence), or babies admitted to NICU (RR 1.61, 95% CI 0.43 to 6.05; 215 infants; 3 studies; low-quality evidence). There were no uterine ruptures in either the PGE₂ group or placebo group.There was no information on vaginal birth not achieved within 24 hours, length of hospital stay, use of emergency services, mother or caregiver satisfaction, or serious morbidity or neonatal morbidity or perinatal death. 3. Vaginal misoprostol versus placebo (4 studies)One small study reported on the rate of perinatal death with no clear differences between groups; there were no deaths in the treatment group compared with one stillbirth (reason not reported) in the control group (RR 0.34, 95% CI 0.01 to 8.14; 77 infants; 1 study; low-quality evidence).There was no clear difference between groups in rates of uterine hyperstimulation with FHR changes (RR 1.97, 95% CI 0.43 to 9.00; 265 women; 3 studies; low-quality evidence), caesarean section (RR 0.94, 95% CI 0.61 to 1.46; 325 women; 4 studies; low-quality evidence), and babies admitted to NICU (RR 0.89, 95% CI 0.54 to 1.47; 325 infants; 4 studies; low-quality evidence).There was no information on vaginal birth not achieved within 24, 48 or 72 hours, additional induction agents required, length of hospital stay, use of emergency services, mother or caregiver satisfaction, serious maternal, and other neonatal, morbidity or death.No substantive differences were found for other comparisons. One small study found that women who received oral misoprostol were more likely to give birth within 24 hours (RR 0.65, 95% CI 0.48 to 0.86; 87 women; 1 study) and were less likely to require additional induction agents (RR 0.60, 95% CI 0.37 to 0.97; 127 women; 2 studies). Women who received mifepristone were also less likely to require additional induction agents (average RR 0.59, 95% CI 0.37 to 0.95; 311 women; 4 studies; I² = 74%); however, this result should be interpreted with caution due to high heterogeneity. One trial each of acupuncture and outpatient amniotomy were included, but few review outcomes were reported.
AUTHORS' CONCLUSIONS
Induction of labour in outpatient settings appears feasible and important adverse events seem rare, however, in general there is insufficient evidence to detect differences. There was no strong evidence that agents used to induce labour in outpatient settings had an impact (positive or negative) on maternal or neonatal health. There was some evidence that compared to placebo or no treatment, induction agents administered on an outpatient basis reduced the need for further interventions to induce labour, and shortened the interval from intervention to birth.We do not have sufficient evidence to know which induction methods are preferred by women, the interventions that are most effective and safe to use in outpatient settings, or their cost effectiveness. Further studies where various women-friendly outpatient protocols are compared head-to-head are required. As part of such work, women should be consulted on what sort of management they would prefer.
Topics: Acupuncture Therapy; Ambulatory Care; Cesarean Section; Dinoprostone; Feasibility Studies; Female; Humans; Intensive Care, Neonatal; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 28901007
DOI: 10.1002/14651858.CD007701.pub3