Clinical trial NCT03399266: Balloon Induction of Labor in PROM for TOLAC
Official title: Mechanical Induction of Labor in Women With Previous Cesarean Section and Premature Rupture of Membranes Who Desire TOLAC: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
Prelabor Rupture of Membranes
Keywords: Induction of labor
Previous cesarean delivery
Trial of labor after cesarean
Prelabor rupture of membranes
balloon induction
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 pregnant women with one previous cesarean section and PROM along with an unfavourable cervix (Bishop Score ≤ 6) are expected to be entered into the study.

All eligible women will be presented with the study protocol by a study coordinator.The following screening medical procedures will be completed:

Medical and gynecological history, physical and vaginal speculum examination, Ultrasonography and a non-stress test (NST).

For eligible patients, and following an informed consent, group randomization will take place:

GROUP 1: Expectant management (standard protocol). GROUP 2: Insertion of a balloon cervical catheter (study group).

The randomization process will be as follows:

A. The eligible patient will sign the informed consent prior to randomization. B. The patient will receive a subject number for the study (from 1 to 200) The study coordinator will open a sealed envelope with the patient's study number to reveal the patient's assigned study group.
Primary purpose: TREATMENT

Brief summary: A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).


Eligibility criteria: Inclusion Criteria:

Only patients who meet the following criteria will be approached.

1. Singleton Pregnancy
2. Previous single cesarean section
3. At least 12 months have elapsed since the previous caesarean delivery
4. Diagnosed with confirmed PROM at ≥ 34 weeks' gestation.
5. Ruptured membranes have occurred ≤24 hours prior to inclusion in the study.
6. Vertex presentation well applied to the cervix
7. Found to have an unripe cervix in a speculum examination (Bishop score ≤6).
8. Absence of significant and regular uterine contraction (\<3/10Min).
9. Willingness to comply with the protocol for the duration of the study.
10. Have signed an informed consent (including a TOLAC consent form).

Exclusion Criteria:

Patients having any of the following conditions will be excluded from the study:

1. Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery \< 12 months).
2. Regular uterine contractions (\>3/10Min).
3. Diagnosis of ruptured membranes was made over 24 hours prior to study inclusion.
4. Meconium stained amniotic fluid.
5. Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000)
6. Suspected placental abruption or a significant hemorrhage.
7. Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.

Primary outcomes:
measure: Vaginal birth after cesarean (VBAC) rates
timeFrame: 5 days
Secondary outcomes:
measure: PROM to delivery interval (time)
timeFrame: 5 days
measure: intrapartum and post-partum infection rates
timeFrame: 5 days
measure: Cesarean section rates
timeFrame: 5 days
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
References: