Clinical trial NCT02720978: Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin
Official title: Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fetus or Newborn or Maternal; Effects of Induction of Labor
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-28
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The duration from the beginning of labor induction until delivery
timeFrame: 5 days
Secondary outcomes:
measure: Duration of labor induction from rupture of membranes until delivery.
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Sharon Maslovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: