Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin

Phase 3

• Conditions: Fetus or Newborn or Maternal; Effects of Induction of Labor
• Interventions: Drug: Intravenous oxytocin; Drug: vaginal prostaglandin

• Registration Number: NCT02720978
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-28
• Status Verified: 2016-05
• Study Start: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous oxytocin	Intravenous oxytocin	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: 1. Verification rupture of membranes and gestational age. 2. Choosing the treatment group Intravenous oxytocin from red envelope, randomly. 3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. 4. Induction according to departmental protocol of each delivery way. 5. Data collecting after the delivery.
vaginal prostaglandin	vaginal prostaglandin	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: 1. Verification rupture of membranes and gestational age. 2. Choosing the treatment group vaginal prostaglandin from red envelope, randomly. 3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. 4. Induction according to departmental protocol of each delivery way. 5. Data collecting after the delivery.

Primary Outcome Measures

Name	Time	Method
The duration from the beginning of labor induction until delivery	5 days

Secondary Outcome Measures

Name	Time	Method
Duration of labor induction from rupture of membranes until delivery.	5 days