NCT03399266

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

January 8, 2018

Last Update Submit

November 8, 2018

Conditions

Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or NewbornPrelabor Rupture of Membranes

Keywords

Induction of laborPrevious cesarean deliveryTrial of labor after cesareanPrelabor rupture of membranesballoon induction

Outcome Measures

Primary Outcomes (1)

  • Vaginal birth after cesarean (VBAC) rates

    5 days

Secondary Outcomes (3)

  • PROM to delivery interval (time)

    5 days

  • intrapartum and post-partum infection rates

    5 days

  • Cesarean section rates

    5 days

Study Arms (2)

Double balloon catheter for induction of labor

EXPERIMENTAL

in this group a trans-cervical double balloon catheter will be inserted. Following device insertion, 20 minutes of external monitoring is performed. The patient will be transferred to the Ob/Gyn ward for hospitalization. 12 hours after insertion of the device the balloons are deflated and the device removed. At this stage the patient is assessed for a second Bishop score and expectant management is resuming.

Device: Double Balloon catheter for induction of labor

Expectant management

NO INTERVENTION

Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues.

Interventions

Double Balloon catheter for induction of laborDEVICE

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.

Also known as: Atad Ripener Device
Double balloon catheter for induction of labor

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Only patients who meet the following criteria will be approached.
  • Singleton Pregnancy
  • Previous single cesarean section
  • At least 12 months have elapsed since the previous caesarean delivery
  • Diagnosed with confirmed PROM at ≥ 34 weeks' gestation.
  • Vertex presentation well applied to the cervix
  • Found to have an unripe cervix in a speculum examination (Bishop score ≤6).
  • Absence of significant and regular uterine contraction (\<3/10Min).
  • Willingness to comply with the protocol for the duration of the study.
  • Have signed an informed consent (including a TOLAC consent form).

You may not qualify if:

  • Patients having any of the following conditions will be excluded from the study:
  • Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery \< 12 months).
  • Regular uterine contractions (\>3/10Min).
  • Meconium stained amniotic fluid.
  • Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000)
  • Suspected placental abruption or a significant hemorrhage.
  • Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

RECRUITING

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

MeSH Terms

Conditions

Pregnancy ComplicationsFetal Membranes, Premature Rupture

Interventions

Labor, Induced

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor Complications

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Gil Gutvirtz, MD

CONTACT

972509630022Giltzik@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ob/Gyn Resident

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2021

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)