Cervical Ripening in Premature Rupture of Membranes
|ClinicalTrials.gov Identifier: NCT02314728|
Recruitment Status : Unknown
Verified March 2016 by Montefiore Medical Center.
Recruitment status was: Recruiting
First Posted : December 11, 2014
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Premature Rupture of Membranes Preterm Premature Rupture of Membranes||Drug: Misoprostol Drug: Oxytocin||Not Applicable|
We will perform a prospective randomized control trial involving women with singleton gestation at ≥ 34 weeks gestation who require an induction of labor after diagnosis of PROM with an unfavorable cervix. PROM will be diagnosed and confirmed with sterile speculum examination demonstrating pooling and/or positive ferning or nitrazine. Cervical status will be assessed by visual exam, digital exam or transvaginal ultrasound to assign a Bishop score (dilation, effacement, station, consistency & position). Determination of patient eligibility will be based on the clinical exam and confirmation of PROM. Upon diagnosis, if the patient meets inclusion criteria and accepts to participate in the study, they will be consented by the study investigator and then be randomized to prostaglandin followed by oxytocin or oxytocin alone group. Allocation concealment will be performed via the utilization of pre-sequentially numbered, manila sealed envelopes stapled closed.
There are two treatment groups and will be analyzed on an intent-to-treat basis. Randomization will be performed using a computer generated simple randomization sequence. Data safety monitoring will be instituted (see data safety monitoring plan below). Once randomization is completed, the labor and delivery providers will be informed of the treatment arm and this will be placed on the chart. Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol. Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol until adequate contractions. Further management after the start of the respective arm will be based on clinical judgment of the provider.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cervical Ripening in Premature Rupture of Membranes|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
Active Comparator: Misoprostol
Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.
Patients who are randomized to receive misoprostol will have 25mcg placed vaginally. Repeated dosing of misoprostol is based on clinical exam and clinical judgment of the provider.
Other Name: Cytotec
Active Comparator: Oxytocin Alone
Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.
Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions.
Other Name: Pitocin
- Rate of Cesarean Section [ Time Frame: 18 months ]Mode of delivery via cesarean section or vaginal delivery
- Maternal and Neonatal Infectious Morbidity [ Time Frame: 24 months ]Maternal infection defined as fever >100.4 on at least two occasions, continued antibiotic treatment on or after PPD#1 up to 6 weeks postpartum or pathological confirmation of infection. Neonatal infection defined as WBC <5000 and absolute neutrophil count <1000 or positive blood cultures and neonatal fever
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314728
|Contact: Kafui Demasio, MD, MPHemail@example.com|
|Contact: Sasha Davidson, MDfirstname.lastname@example.org|
|Principal Investigator:||Kafui Demasio, MD, MPH||Montefiore Medical Center|