Overview

This trial is active, not recruiting.

Condition fetus or newborn or maternal; effects of induction of labor
Treatments intravenous oxytocin, vaginal prostaglandin
Phase phase 3
Sponsor Tel-Aviv Sourasky Medical Center
Start date May 2016
End date May 2019
Trial size 1200 participants
Trial identifier NCT02720978, 0073-15-TLV

Summary

Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps: Verification rupture of membranes and gestational age. Choosing the treatment group Intravenous oxytocin from red envelope, randomly. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery.
intravenous oxytocin
Intravenous oxytocin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery.
(Experimental)
Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps: Verification rupture of membranes and gestational age. Choosing the treatment group vaginal prostaglandin from red envelope, randomly. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery.
vaginal prostaglandin
Vaginal prostaglandin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery.

Primary Outcomes

Measure
The duration from the beginning of labor induction until delivery
time frame: 5 days

Secondary Outcomes

Measure
Duration of labor induction from rupture of membranes until delivery.
time frame: 5 days

Eligibility Criteria

Female participants from 18 years up to 42 years old.

Inclusion Criteria: 1. rupture of membranes in BISHOP score lower than 7. 2. Pregnancy week 34+0 and onward. 3. Singleton pregnancy. 4. Verifying fetal monitoring. 5. Normal maternal temperature (lower than 37.8) 6. Without vaginal bleeding or suspected placental separation 7. Contractions in frequency of less than 3 in 10 minutes 8. Signed consent form. Exclusion Criteria: 1. Multiple pregnancy. 2. Maternal age below 18 or over 42. 3. Active labor 4. Contractions in frequency of more than 3 in 10 minutes or cervical dilation ≥2 cm. 5. Lack of consent to participate in the study

Additional Information

Official title Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin
Principal investigator Sharon Maslovitz, MD
Description Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration. Therefore, the aim of the study is to compare randomly the perinatal outcomes in women with PROM and low BISHOP between women who undergo labor induction with Oxytocin and women who undergo labor induction with Prostaglandin E2.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center.