Balloon Induction of Labor in PROM for TOLAC

Prelabor Rupture of Membranes Clinical Trial

— BILROM-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399266
• Other study ID #: SOR-0019-17-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 2021

Study information

• Verified date: November 2018
• Source: Soroka University Medical Center
• Contact: Gil Gutvirtz, MD
• Phone: 972509630022
• Email: Giltzik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Pregnancy Complications
• Prelabor Rupture of Membranes
• Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
• Rupture

Intervention

Device:
• Double Balloon catheter for induction of labor
With the patient in lithotomy position or lying supine in bed, a speculum is inserted to visualise the cervix. The device is inserted into the cervix using long forceps until both balloons enter the cervical canal. Then, the uterine balloon is inflated with 20 ml of saline (by means of a 20 ml syringe). The device is then pulled out until stopped by the uterine balloon covering the internal cervical os. At this point the cervico-vaginal balloon located at the external os is inflated with 20 ml of saline and the speculum is removed. Then both balloons are additionally inflated with alternate increments of 20 ml normal saline to a total volume of 80 ml in each balloon. The device is loosely taped to the patient's inner thigh.

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal birth after cesarean (VBAC) rates		5 days
Secondary	PROM to delivery interval (time)		5 days
Secondary	intrapartum and post-partum infection rates		5 days
Secondary	Cesarean section rates		5 days