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

NCT ID: NCT02720978

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-05-31

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.

Conditions

Fetus or Newborn or Maternal; Effects of Induction of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intravenous oxytocin

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

vaginal prostaglandin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Maslovitz, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Other Identifiers

0073-15-TLV

Identifier Type: -

Identifier Source: org_study_id