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

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.

Study Overview

• Status: Unknown
• Conditions: Fetus or Newborn or Maternal; Effects of Induction of Labor
• Intervention / Treatment: Drug: Intravenous oxytocin; Drug: vaginal prostaglandin

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 Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.	Drug: 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: 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: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The duration from the beginning of labor induction until delivery	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of labor induction from rupture of membranes until delivery.	5 days

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Sharon Maslovitz, MD, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: March 25, 2016
• First Posted (Estimate): March 28, 2016

Study Record Updates

• Last Update Posted (Estimate): May 26, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 0073-15-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO