Fetus or Newborn or Maternal; Effects of Induction of Labor
Conditions
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.
Interventions
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 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.
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The duration from the beginning of labor induction until delivery | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Duration of labor induction from rupture of membranes until delivery. | 5 days |
Outcome results
None listed