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BMJ Open May 2024Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and...
Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies.
INTRODUCTION
Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.
METHODS AND ANALYSIS
We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at <24 weeks of gestation and an asymptomatic short cervix of ≤25 mm or cervical dilatation will be randomly allocated (1:1) to both trials on vaginal cerclage and standard treatment according to the current Dutch Society of Obstetrics and Gynaecology guideline (no cerclage). Permuted blocks sized 2 and 4 will be used to minimise the risk of disbalance. The primary outcome measure is PTB of <28 weeks. Analyses will be by intention to treat. The first trial is to demonstrate a risk reduction from 25% to 10% in the short cervix group, for which 194 patients need to be recruited. The second trial is to demonstrate a risk reduction from 80% to 35% in the dilatation group and will recruit 44 women. A cost-effectiveness analysis will be performed from a societal perspective.
ETHICS AND DISSEMINATION
This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov, NCT05968794.
Topics: Humans; Female; Pregnancy; Cerclage, Cervical; Pregnancy, Twin; Premature Birth; Randomized Controlled Trials as Topic; Perinatal Mortality; Netherlands; Infant, Newborn; Multicenter Studies as Topic; Cervix Uteri; Adult
PubMed: 38729756
DOI: 10.1136/bmjopen-2023-081561 -
Journal of Education & Teaching in... Apr 2024This scenario was developed to educate emergency medicine residents on the diagnosis and management of two concurrent conditions: septic abortion and disseminated...
AUDIENCE
This scenario was developed to educate emergency medicine residents on the diagnosis and management of two concurrent conditions: septic abortion and disseminated intravascular coagulation (DIC).
INTRODUCTION
Patients with an abortion (spontaneous or induced) of less than twenty weeks gestation may present with concurrent uterine infection, also known as septic abortion. One of the complications of septic abortion is DIC. Early management of both underlying etiology (septic abortion) and subsequent complications (DIC) is crucial to minimize morbidity and mortality.
EDUCATIONAL OBJECTIVES
At the conclusion of the simulation session, learners will be able to: 1) Obtain a relevant focused history including pregnancy history, medication use, and past medical history. 2) Develop a differential for fever and vaginal bleeding in a pregnant patient. 3) Discuss management of septic abortion, including empiric broad-spectrum antibiotics and obstetric consultation for source control with dilation and curettage (D&C). 4) Discuss expected laboratory findings of disseminated intravascular coagulation (DIC). 5) Discuss management of DIC, including identification of underlying etiology and supportive resuscitation with blood products. 6) Review the components of blood products. 7) Identify appropriate disposition of the patient to the intensive care unit (ICU).
EDUCATIONAL METHODS
This session was conducted using high-fidelity simulation followed by a debriefing session and discussion about the diagnosis, differential, and management of both septic abortion and DIC. Debriefing methods may be left to the discretion of participants, but the authors have utilized advocacy-inquiry techniques. In this technique, the facilitator described something they observed in the case, outlined their reasoning as a facilitator why this observation was important or why they had questions, and then asked the learners to share their frame of reference at the time. An example: "I heard the team leader state that the platelets were normal, but then another resident disagreed. No one paused to come to a consensus. I'm wondering why this wasn't explored further in real time. Tell me more." This scenario may also be run as an oral boards case or adapted for other learners such as critical care fellows.
RESEARCH METHODS
Our residents were provided a survey at the completion of the debriefing session so they could rate different aspects of the simulation, as well as provide qualitative feedback on the scenario. The local institution's simulation center's electronic feedback form is based on the Center of Medical Simulation's Debriefing Assessment for Simulation in Healthcare (DASH) Student Version Short Form,1 with the inclusion of required qualitative feedback if an element was scored less than a 6 or 7.
RESULTS
Thirteen learners completed a feedback form out of seventeen participants. This session received all six and seven scores (consistently effective/very good and extremely effective/outstanding, respectively) other than two isolated 4 scores.
DISCUSSION
This is a cost-effective method for reviewing septic abortion and DIC. The case may be modified for appropriate audiences, such as simplifying the case to septic abortion without DIC. You can also consider not showing an initial temperature with the initial set of vitals unless it is specifically asked for by the participants. We encourage readers to utilize bleeding moulage techniques as a visual stimulus to increase psychological buy-in.
TOPICS
Medical simulation, septic abortion, pregnancy complications, hematology emergencies, obstetric emergencies, disseminated intravascular coagulation, emergency medicine.
PubMed: 38707944
DOI: 10.21980/J8GH1G -
Journal of Education & Teaching in... Apr 2024Uterine perforation is a rare but potentially life-threatening complication of gynecologic procedures. Serious complications include hemorrhage, infection, and injury to...
UNLABELLED
Uterine perforation is a rare but potentially life-threatening complication of gynecologic procedures. Serious complications include hemorrhage, infection, and injury to surrounding organ systems (eg, gastrointestinal, urological, vascular, etc.). Risk factors include advanced maternal age, prior gynecologic surgeries, and other anatomical features that impact the difficulty of accessing the uterine cavity. In this case report, we discuss a patient who presented to the emergency department (ED) with diffuse abdominal pain and vaginal bleeding that occurred after an elective dilation and curettage (D&C) for a termination of pregnancy. The diagnosis was suspected clinically and confirmed by imaging including ultrasound (US) and computed tomography (CT) of the abdomen and pelvis. The patient was managed operatively with a multidisciplinary approach including Gynecology, General Surgery, and Urology. The patient was stabilized and eventually discharged. Uterine perforation should be included in the differential for patients with a history of recent gynecologic instrumentation presenting with abdominal pain and vaginal bleeding. The stabilization of these patients requires aggressive volume resuscitation, controlling the source of bleeding, and emergent surgical consultation.
TOPICS
Gynecology, vaginal bleeding, ultrasound, computed tomography.
PubMed: 38707940
DOI: 10.21980/J83643 -
International Journal of Surgery Case... Jun 2024Uterine artery pseudoaneurysm is an extraluminal collection of blood caused by damage to the arterial wall which can result from cesarean section, myomectomy,...
INTRODUCTION AND IMPORTANCE
Uterine artery pseudoaneurysm is an extraluminal collection of blood caused by damage to the arterial wall which can result from cesarean section, myomectomy, hysterectomy, laparoscopic excision of deep endometriotic lesions, dilation and curettage and uterine cervical conization. Uterine artery pseudoaneurysm may go unnoticed as a possible cause of post-partum hemorrhage.
CASE PRESENTATION
We report a case of 25 years female who presented with 3 episodes of per vaginal bleeding on the 34th postoperative day of cesarean section. Computed tomography angiogram confirmed the aneurysm of the left uterine artery and the artery was embolized for the management of aneurysm. Follow-up scan showed normal blood flow and her symptoms were relieved after the procedure.
DISCUSSION
Uterine artery pseudoaneurysm can be diagnosed by Doppler ultrasound which shows intrauterine mass with swirling blood flow. The gold standard investigation is computed tomography angiography. Uterine artery embolization is the recent treatment approach which is both safe and effective.
CONCLUSION
Women who present with postpartum vaginal bleeding should be promptly evaluated for uterine artery pseudoaneurysm. Uterine artery pseudoaneurysm can then be effectively managed through embolization, ensuring timely intervention and improved maternal health outcomes.
PubMed: 38678997
DOI: 10.1016/j.ijscr.2024.109697 -
Urology Jun 2024To describe urinary tract infection (UTI) risk 3-month postvaginoplasty (VP) in transgender women (TW) compared to cis women (CW). (Comparative Study)
Comparative Study
OBJECTIVE
To describe urinary tract infection (UTI) risk 3-month postvaginoplasty (VP) in transgender women (TW) compared to cis women (CW).
METHODS
Using TriNetX (TriNetX, Inc, Cambridge, MA), we built cohorts of 2041 TW and 48,374,745 CW. Outcomes were ≥1 instance of UTI or Cystitis, and assessed from 3-6, 3-12, 3-36months, and 3months-10years post-VP. TW and CW were age-cohorted (18-39, 40-59, 60-74) and compared at each time interval. Kaplan-Meier was used to account for loss to follow-up, along with hazard ratios and log-rank tests to determine significance (P <.05).
RESULTS
For all time intervals and age ranges, TW had a significantly (P <.0001-P = .0088) higher probability of developing a UTI compared to CW. The largest difference was ages 40-59 ten-year post-VP. In this analysis, CW and TW had a 12.96% and 29.34% cumulative outcome incidence, respectively. Cox proportional hazard analysis demonstrated increased hazard for TW compared to CW. Hazard ratios between CW and TW ranged from 1.363 (ages 18-39 at 10years, 95%CI: 1.119,1.660) to 3.522 (ages 60-74 at 12months, 95%CI: 1.951,6.360).
CONCLUSION
We found a significantly higher probability of TW developing UTIs compared to age-cohorted CW. Contributing factors may include difficulties with neovaginal perineal hygiene, lack of commensal bacteria and vaginal mucosa, larger urethral meatus, high rates of meatal stenosis, and nonnative bacteria introduced through dilators and douching. These findings may help improve quality of postoperative care in TW.
Topics: Humans; Female; Retrospective Studies; Adult; Middle Aged; Urinary Tract Infections; Vagina; Adolescent; Young Adult; Aged; Postoperative Complications; United States; Transgender Persons; Male; Cohort Studies
PubMed: 38657871
DOI: 10.1016/j.urology.2024.04.004 -
BMC Pregnancy and Childbirth Apr 2024Childbirth may be associated with psychological, social, and emotional effects and provide the background for women's health or illness throughout their life. This... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
The comparison of the effect of non-pharmacological pain relief and pharmacological analgesia with remifentanil on fear of childbirth and postpartum depression: a randomized controlled clinical trial.
INTRODUCTION
Childbirth may be associated with psychological, social, and emotional effects and provide the background for women's health or illness throughout their life. This research aimed at comparing the impact of non-pharmacological pain relief and pharmacological analgesia with remifentanil on childbirth fear and postpartum depression.
MATERIALS AND METHOD
This randomized clinical trial with two parallel arms was conducted on 66 women with term pregnancy referred to Taleghani Hospital in Tabriz for vaginal delivery during September 2022 to September 2023. First, all of the eligible participants were selected through Convenience Sampling. Then, they were randomly assigned into two groups of pharmacological analgesia with remifentanil and non-pharmacological analgesia with a ratio of 1:1 using stratified block randomization based on the number of births. Before the intervention, fear of childbirth (FOC) was measured using Delivery Fear Scale (DFS) between 4 and 6 cm cervical dilatation. Pain and fear during labor in dilatation of 8 cm were measured in both groups using VAS and DFS. After delivery, FOC was assessed using Delivery Fear Scale (W DEQ Version B) and postpartum depression using the Edinburgh's postpartum depression scale (EPDS). Significance level was considered 0.05. Mean difference (MD) was compared with Independent T-test and ANCOVA pre and post intervention.
RESULTS
The mean score of FOC in the non-pharmacological analgesia group was significantly lower than that in the pharmacological analgesia group after the intervention by controlling the effect of the baseline score (MD: -6.33, 95%, Confidence Interval (CI): -12.79 to -0.12, p = 0.04). In the postpartum period, the mean score of FOC in the non-pharmacological analgesia group was significantly lower than that in the pharmacological analgesia group after controlling the effect of the baseline score (MD: -21.89; 95% CI: -35.12 to -8.66; p = 0.002). The mean score of postpartum depression in the non-pharmacological analgesia group was significantly lower than that in the pharmacological analgesia group (MD: -1.93, 95% CI: -3.48 to -0.37, p = 0.01).
TRIAL REGISTRATION
Iranian Registry of Clinical Trials (IRCT): IRCT20170506033834N10. Date of registration: 05/07/2022 Date of first registration: 05/07/2022. URL: https://www.irct.ir/trial/61030; Date of recruitment start date05/07/2022.
CONCLUSION
The study results indicated a reduction in FOC and postpartum depression among parturient women receiving non-pharmacological strategies with active participation in childbirth compared to women receiving pharmacological analgesia. Owing to the possible side effects of pharmacological methods for mother and fetus, non-pharmacological strategies with active participation of the mother in childbirth are recommended to reduce the FOC and postpartum depression.
Topics: Humans; Female; Depression, Postpartum; Adult; Pregnancy; Fear; Remifentanil; Parturition; Pain Management; Analgesics, Opioid; Analgesia, Obstetrical; Labor Pain; Iran; Delivery, Obstetric; Pain Measurement
PubMed: 38654255
DOI: 10.1186/s12884-024-06270-z -
Archives of Gynecology and Obstetrics Jul 2024Cervical cerclage is the only effective treatment for cervical insufficiency, effectively preventing late miscarriage and preterm birth. The effectiveness and safety of...
BACKGROUND
Cervical cerclage is the only effective treatment for cervical insufficiency, effectively preventing late miscarriage and preterm birth. The effectiveness and safety of emergency cervical cerclage (ECC) as an emergency treatment when the cervix is already dilated or when there is protrusion of the fetal membranes into the vagina remain controversial, especially in pregnancies at 24-28 weeks when the fetus is viable. There is still no consensus on whether emergency cervical cerclage should be performed in such cases.
PURPOSE
To investigate the effectiveness and safety of emergency cervical cerclage in singleton pregnant women at 24-28 weeks of gestation.
METHODS
This study employed a single-center prospective cohort design, enrolling singleton pregnant women at 24-28 weeks of gestation with ultrasound or physical examination indicating cervical dilation or even membrane protrusion. Emergency cervical cerclage was compared with conservative treatment. The primary endpoints included a comprehensive assessment of perinatal pregnancy loss, significant neonatal morbidity, and adverse neonatal outcomes. Secondary endpoints included prolonged gestational age, preterm birth, neonatal hospitalization rate, premature rupture of membranes, and intrauterine infection/chorioamnionitis.
RESULTS
From June 2021 to March 2023, a total of 133 pregnant women participated in this study, with 125 completing the trial, and were allocated to either the Emergency Cervical Cerclage (ECC) group (72 cases) or the conservative treatment group (53 cases) based on informed consent from the pregnant women. The rate of adverse neonatal outcomes was 8.33% in the ECC group and 26.42% in the conservative treatment (CT) group, with a statistically significant difference (P = 0.06). There were no significant differences between the two groups in terms of perinatal pregnancy loss and significant neonatal morbidity. The conservative treatment group had a mean prolonged gestational age of 63.0 (23.0, 79.5) days, while the ECC group had 84.0 (72.5, 89.0) days, with a statistically significant difference between the two groups (P < 0.001). Compared with CT group, the ECC group showed a significantly reduced incidence of preterm birth before 28 weeks, 32 weeks, and 34 weeks, with statistical significance (P = 0.046, 0.007, 0.001), as well as a significantly decreased neonatal hospitalization rate (P = 0.013, 0.031). Additionally, ECC treatment did not increase the risk of preterm premature rupture of membranes or intrauterine infection/chorioamnionitis, with no statistically significant differences (P = 0.406, 0.397).
CONCLUSION
In singleton pregnant women with cervical insufficiency at 24-28 weeks of gestation, emergency cervical cerclage can reduce adverse neonatal pregnancy outcomes, effectively prolong gestational age, decrease preterm births before 28 weeks, 32 weeks, and 34 weeks, lower neonatal hospitalization rates, and does not increase the risk of preterm premature rupture of membranes or intrauterine infection/chorioamnionitis.
Topics: Humans; Female; Pregnancy; Cerclage, Cervical; Adult; Prospective Studies; Premature Birth; Uterine Cervical Incompetence; Gestational Age; Pregnancy Outcome; Infant, Newborn; Pregnancy Trimester, Second; Fetal Membranes, Premature Rupture; Emergencies; Abortion, Spontaneous; Emergency Treatment
PubMed: 38649500
DOI: 10.1007/s00404-024-07493-3 -
BMC Pregnancy and Childbirth Apr 2024Current guidelines regarding oxytocin stimulation are not tailored to individuals as they are based on randomised controlled trials. The objective of the study was to...
Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX): individual management based on artificial intelligence - a secondary analysis.
BACKGROUND
Current guidelines regarding oxytocin stimulation are not tailored to individuals as they are based on randomised controlled trials. The objective of the study was to develop an artificial intelligence (AI) model for individual prediction of the risk of caesarean delivery (CD) in women with a cervical dilatation of 6 cm after oxytocin stimulation for induced labour. The model included not only variables known when labour induction was initiated but also variables describing the course of the labour induction.
METHODS
Secondary analysis of data from the CONDISOX randomised controlled trial of discontinued vs. continued oxytocin infusion in the active phase of induced labour. Extreme gradient boosting (XGBoost) software was used to build the prediction model. To explain the impact of the predictors, we calculated Shapley additive explanation (SHAP) values and present a summary SHAP plot. A force plot was used to explain specifics about an individual's predictors that result in a change of the individual's risk output value from the population-based risk.
RESULTS
Among 1060 included women, 160 (15.1%) were delivered by CD. The XGBoost model found women who delivered vaginally were more likely to be parous, taller, to have a lower estimated birth weight, and to be stimulated with a lower amount of oxytocin. In 108 women (10% of 1060) the model favoured either continuation or discontinuation of oxytocin. For the remaining 90% of the women, the model found that continuation or discontinuation of oxytocin stimulation affected the risk difference of CD by less than 5% points.
CONCLUSION
In women undergoing labour induction, this AI model based on a secondary analysis of data from the CONDISOX trial may help predict the risk of CD and assist the mother and clinician in individual tailored management of oxytocin stimulation after reaching 6 cm of cervical dilation.
Topics: Pregnancy; Female; Humans; Oxytocin; Oxytocics; Artificial Intelligence; Labor, Obstetric; Labor, Induced
PubMed: 38641779
DOI: 10.1186/s12884-024-06461-8 -
Health Science Reports Apr 2024Due to the concern about the side effects of chemical drugs and their ineffectiveness, the use of natural compounds as alternatives or complementary therapies has...
BACKGROUND AND AIM
Due to the concern about the side effects of chemical drugs and their ineffectiveness, the use of natural compounds as alternatives or complementary therapies has received increasing attention. The purpose of this study was to investigate the effect of oil on the outcome of missed abortion.
METHODS
In this double-blind clinical trial, 70 nulliparous pregnant women referred to Hajar Hospital and Imam Ali clinics of Shahrekord and had missed abortion before the 12-week gestational age were selected and randomly divided into two interventions and control groups. The intervention group received 5 g of oil alone daily for up to 3 days and the control group received a placebo. In case of nonresponse, 3 days after the last dose of medication or placebo, 800 μg of misoprostol (vaginal) were used. Data were analyzed by SPSS software. The chi-square test, Fisher's exact test, independent -test and paired -test were used for analytical statistics.
RESULTS
According to the results, 18 cases (51.4%) in the intervention group and seven cases (20%) in the control group showed complete evacuation of uterine contents which had a significant difference ( < 0.05). The frequency of vagina physical examination and type of hemorrhage did not show any significant difference between the two groups before and after the intervention. After the intervention, human chorionic gonadotropin (HCG) was significantly decreased in the intervention group but did not change in the control group ( < 0.05). The frequency of adverse events in the intervention group was three (8.6%) and in the control group was one (2.9%) which had no significant difference.
CONCLUSION
improves the outcome of missed abortion by reducing HCG and facilitating cervix dilatation and delivery of uterine contents.
PubMed: 38633734
DOI: 10.1002/hsr2.2029 -
BMC Pregnancy and Childbirth Apr 2024In 2018, the World Health Organization published a set of recommendations for further emphasis on the quality of intrapartum care to improve the childbirth experience.... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In 2018, the World Health Organization published a set of recommendations for further emphasis on the quality of intrapartum care to improve the childbirth experience. This study aimed to determine the effects of the WHO intrapartum care model on the childbirth experience, fear of childbirth, the quality of intrapartum care (primary outcomes), as well as post-traumatic stress disorder symptoms, postpartum depression, the duration of childbirth stages, the frequency of vaginal childbirth, Apgar score less than 7, desire for subsequent childbearing, and exclusive breastfeeding in the 4 to 6 weeks postpartum period (secondary outcomes).
METHODS
This study was a randomized controlled trial involving 108 pregnant women admitted to the maternity units of Al-Zahra and Taleghani hospitals in Tabriz-Iran. Participants were allocated to either the intervention group, which received care according to the ' 'intrapartum care model, or the control group, which received the' 'hospital's routine care, using the blocked randomization method. A Partograph chart was drawn for each participant during pregnancy. A delivery fear scale was completed by all participants both before the beginning of the active phase (pre-intervention) and during 7 to 8 cm dilation (post-intervention). Participants in both groups were followed up for 4 to 6 weeks after childbirth and were asked to complete questionnaires on childbirth experience, postpartum depression, and post-traumatic stress disorder symptoms, as well as the pregnancy and childbirth questionnaire and checklists on the desire to have children again and exclusive breastfeeding. The data were analyzed using independent T and Mann-Whitney U tests and analysis of covariance ANCOVA with adjustments for the parity variable and the baseline scores or childbirth fear.
RESULTS
The average score for the childbirth experience total was notably higher in the intervention group (Adjusted Mean Difference (AMD) (95% Confidence Interval (CI)): 7.0 (0.6 to 0.8), p < 0.001). Similarly, the intrapartum care quality score exhibited a significant increase in the intervention group (AMD (95% CI): 7.0 (4.0 to 10), p < 0.001). Furthermore, the post-intervention fear of childbirth score demonstrated a substantial decrease in the intervention group (AMD (95% CI): -16.0 (-22.0 to -10.0), p < 0.001). No statistically significant differences were observed between the two groups in terms of mean scores for depression, PTSD symptoms, duration of childbirth stages, frequency of vaginal childbirth, Apgar score less than 7, and exclusive breastfeeding in the 4 to 6 weeks postpartum (p > 0.05).
CONCLUSION
The intrapartum care model endorsed by the World Health Organization (WHO) has demonstrated effectiveness in enhancing childbirth experiences and increasing maternal satisfaction with the quality of obstetric care. Additionally, it contributes to the reduction of fear associated with labor and childbirth. Future research endeavors should explore strategies to prioritize and integrate respectful, high-quality care during labor and childbirth alongside clinical measures.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Delivery, Obstetric; Depression, Postpartum; Labor, Obstetric; Parturition; Postpartum Period
PubMed: 38632530
DOI: 10.1186/s12884-024-06449-4