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Birth (Berkeley, Calif.) Sep 2023Outpatient induction of labor (IOL) is an alternative choice offered to pregnant women requiring cervical ripening. Outpatient IOL can provide solutions in terms of... (Review)
Review
Outpatient versus inpatient cervical ripening with a slow-release dinoprostone vaginal insert in term pregnancies on maternal, neonatal, and birth outcomes: A systematic review.
BACKGROUNDS
Outpatient induction of labor (IOL) is an alternative choice offered to pregnant women requiring cervical ripening. Outpatient IOL can provide solutions in terms of women empowerment, but most importantly promotes as normal labor as possible, within the medical context of the IOL. The objectives of this systematic review were to assess safety and effectiveness of cervical ripening performed with a slow-release dinoprostone vaginal insert in term pregnancies in two settings: the outpatient (home) versus the inpatient (hospital).
METHODS
The electronic databases Cinahl, Embase, Medline and Maternity and Infant Care were searched to detect studies that met the inclusion criteria. Both reviewers collected the data and assessed the quality of the studies and assessed the pooled odds ratio using a 95% confidence interval and a random-effects model. Primary outcomes were linked to maternal and neonatal morbidity. Secondary outcomes were related to birth outcomes.
RESULTS
No statistical difference was seen between the outpatient and inpatient setting in terms of maternal complications, neonatal morbidity, cesarean section, and labor onset <24 h. Women in the outpatient setting were significantly less likely to experience uterine hyperstimulation, and they were also significantly more likely to require oxytocin to augment or induce their labor than the women in the inpatient setting. Women in the outpatient setting were more satisfied with the cervical ripening experience.
CONCLUSIONS
Cervical ripening with a slow-release dinoprostone vaginal insert in term pregnancies in the outpatient setting appears as safe as the inpatient setting in terms of maternal, neonatal, and birth outcomes.
Topics: Infant, Newborn; Female; Pregnancy; Humans; Dinoprostone; Oxytocics; Cesarean Section; Cervical Ripening; Outpatients; Inpatients; Labor, Induced
PubMed: 36332128
DOI: 10.1111/birt.12687 -
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 -
Reproductive Sciences (Thousand Oaks,... Feb 2023The objective of this study was to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that evaluated isosorbide mononitrate (ISMN)... (Meta-Analysis)
Meta-Analysis Review
The objective of this study was to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that evaluated isosorbide mononitrate (ISMN) versus dinoprostone, a prostaglandin E2 (PGE2) analogue, in promoting cervical ripening during labor induction. We searched five major databases from inception till 02 May 2021. We assessed the risk of bias of included studies. We meta-analyzed various endpoints (n=12) and pooled the endpoints as mean difference (MD) or risk ratio (RR) with 95% confidence interval (CI). Overall, 4 RCTs met the inclusion criteria, comprising 818 patients; equally 409 patients were allocated to ISMN and PGE2 groups. Overall, the RCTs had a low risk of bias. The mean change in Bishop score at 24 h was significantly lower in disfavor of the ISMN group. The mean time from drug administration to delivery was significantly longer in disfavor of the ISMN group. The rate of oxytocin need was significantly higher in disfavor of the ISMN group. The rate of vaginal delivery at 24 h was significantly lower in disfavor of the ISMN group. The rates of headache and palpitations were significantly higher in disfavor of the ISMN group. The rate of abnormal fetal heart rate was significantly lower in favor of the ISMN group. There was no significant difference between both groups with regard to rates of cesarean delivery, postpartum hemorrhage, uterine hyperstimulation, and NICU admission. Compared with PGE2, ISMN appeared less effective for cervical ripening prior to labor induction and correlated with higher drug-related maternal toxicities.
Topics: Pregnancy; Female; Humans; Dinoprostone; Oxytocics; Cervical Ripening; Randomized Controlled Trials as Topic; Labor, Induced
PubMed: 35441336
DOI: 10.1007/s43032-022-00909-y -
PloS One 2021As uterine rupture may affect as many as 11/1000 women with 1 prior cesarean birth and 5/10.000 women with unscarred uterus undergoing labor induction, we intended to... (Meta-Analysis)
Meta-Analysis
Prevalence of uterine rupture among women with one prior low transverse cesarean and women with unscarred uterus undergoing labor induction with PGE2: A systematic review and meta-analysis.
BACKGROUND
As uterine rupture may affect as many as 11/1000 women with 1 prior cesarean birth and 5/10.000 women with unscarred uterus undergoing labor induction, we intended to estimate the prevalence of such rare outcome when PGE2 is used for cervical ripening and labor induction.
METHODS
We searched MEDLINE, ClinicalTrials.gov and the Cochrane library up to September 1st 2020. Retrospective and prospective cohort studies, as well as randomized controlled trials (RCTs) on singleton viable pregnancies receiving PGE2 for cervical ripening and labor induction were reviewed. Prevalence of uterine rupture was meta-analyzed with Freeman-Tukey double arcsine transformation among women with 1 prior low transverse cesarean section and women with unscarred uterus.
RESULTS
We reviewed 956 full text articles to include 69 studies. The pooled prevalence rate of uterine rupture is estimated to range between 2 and 9 out of 1000 women with 1 prior low transverse cesarean (5/1000; 95%CI 2-9/1000, 122/9000). The prevalence of uterine rupture among women with unscarred uterus is extremely low, reaching at most 0.7/100.000 (<1/100.000.000; 95%CI <1/100.000.000-0.7/100.000, 8/17.684).
CONCLUSIONS
Uterine rupture is a rare event during cervical ripening and labor induction with PGE2.
Topics: Adult; Cesarean Section; Dinoprostone; Female; Humans; Labor, Induced; Pregnancy; Prevalence; Publication Bias; Uterine Rupture; Uterus
PubMed: 34228760
DOI: 10.1371/journal.pone.0253957 -
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 -
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