Clinical trial NCT05674487: Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
Official title: Prostaglandins Versus Trans-Cervical Balloon for Induction of Labor in Fetal Growth Restriction: a Multicenter Open-label Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Growth Restriction
Keywords: Fetal growth restriction
Cesarean section
Induction of labor
Cervical ripening
Neonatal morbidity
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: French Ministry of Social Affairs and Health
First posted: 2023-01-06
Enrollment: 774
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized trial is to compare two methods of induction in a fetal growth restriction population. The main question it aims to answer is:

• Is trans-cervical balloon superior to prostaglandins in reducing the cesarean section rate, without increasing neonatal morbidity? Participants will have an induction of labour by cervical ripening with trans-cervical balloon in the trans-cervical balloon catheter arm and with Prostaglandins in the Misoprostol arm.

Researchers will compare two methods of induction: trans-cervical balloon and prostaglandins to see if trans-cervical balloon is associated with a lower risk of cesarean delivery.

Detailed description: Fetal growth restriction (FGR) is associated with increased perinatal morbidity and mortality in late pregnancy. Because of this higher risk of adverse perinatal outcome, induction of labor is often proposed and require cervical ripening when the cervix is not favorable, i.e. Bishop score less than 6. Two methods of cervical ripening are currently available and used: pharmacological (prostaglandins) and mechanical (trans-cervical balloon).

Growth-restricted fetuses are a population at increased risk for non-reassuring fetal status and hypoxia during labor because of their lower weight. Prostaglandins can lead to cardiotocograph (CTG) tracing abnormalities by causing uterine tachysystole in normal-weight fetuses. Nevertheless, the question of the method of induction of labor has been poorly studied in the population of growth-restricted fetuses. None of the national and international societies reports in their guidelines which method of induction of labor should be offered to pregnancies complicated by a fetal growth restriction. A few retrospective studies are in favor of an increased risk of uterine tachysystole with consequences on the CTG tracing in the case of cervical ripening with prostaglandins compared to the trans-cervical balloon. However, the results of these studies lack robustness due to important methodological limitations.

Because trans-cervical balloon is a mechanical method of cervical ripening, it may be less likely to cause uterine tachysystole and thus fewer non-reassuring fetal status. Thus, the risk of cesarean section in labor could be decreased compared with the use of prostaglandins in the growth-restricted fetal population.

To date, there is no published quality randomized controlled trials on the optimal method of cervical ripening in induction of labor for FGR fetuses.

The present large-scale randomized trial aim to define the preferred method of induction for these fetuses, associated with a lower risk of cesarean delivery. If it is demonstrated that one method of induction (trans-cervical balloon) is superior to another (prostaglandins) in reducing the cesarean section rate, without increasing neonatal morbidity, the results of our study are likely to lead to changes in national and international recommendations.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Singleton gestation, with cephalic presentation
* Gestational age at randomization between entre 34 weeks of gestation and 0 day and 41 weeks of gestation and 0 day
* Fetal growth restriction (FGR). FGR is defined at the third trimester by an abdominal circumference below the 10th centile and/or an estimated fetal weight below the 10th centile (according to local curve), according to the trial DIGITAT. Fetus with normal and abnormal Doppler index can be included.
* Plan for induction of labor whatever the indication (fetal growth restriction or other), the induction of labor is the induction of birth by vaginal delivery
* Bishop Score below 6
* Affiliated or beneficiary to a health security system
* Signed informed consent

Exclusion Criteria:

* Contraindication to an induction of labor
* History of previous cesarean delivery, myomectomy by laparotomy or laparoscopy
* Contraindication to misoprostol or trans-cervical balloon
* Known HIV positivity (because of modified delivery plan)
* Known major fetal anomaly or chromosomic anomaly
* Fetal demise
* Patient under legal protection
* Poor understanding of the French language

Primary outcomes:
measure: cesarean section
timeFrame: Day 1
Secondary outcomes:
measure: duration of labor
timeFrame: Day 1
measure: duration between cervical ripening and delivery
timeFrame: Day 1
measure: oxytocin use
timeFrame: Day 1
measure: operative delivery
timeFrame: Day 1
measure: postpartum hemorrhage
timeFrame: Day 3
measure: Mean total blood loss
timeFrame: Day 3
measure: intra-uterine infectious
timeFrame: Day 5
measure: iron administration
timeFrame: Day 5
measure: transfusion
timeFrame: Day 5
measure: maternal thromboembolism event
timeFrame: Day 5
measure: maternal satisfaction
timeFrame: Day 5
measure: Mean duration of hospitalization
timeFrame: Day 5
measure: umbilical artery lactic acid
timeFrame: Day 1
measure: umbilical artery pH
timeFrame: Day 1
measure: neonatal Apgar Score
timeFrame: Day 1
measure: neonatal hypoglycemia
timeFrame: Day 5
measure: neonatal intensive care
timeFrame: Day 5
measure: neonatal length of hospital stay
timeFrame: Day 5 up to Month 2
measure: neonatal death before discharge
timeFrame: Day 1 up to Month 2
measure: non-reassuring fetal status
timeFrame: Day 1
measure: cesarean section for non-reassuring fetal status
timeFrame: Day 1
measure: cesarean section for arrest of labor
timeFrame: Day 1
measure: neonatal ventilation
timeFrame: Day 3
measure: neonatal hypoxic-ischemic encephalopathy
timeFrame: Day 1 up to Month 2
measure: neonatal seizure
timeFrame: Day 1
measure: neonatal infection
timeFrame: Day 1 up to Day 28
measure: neonatal meconium aspiration syndrome
timeFrame: Day 5
measure: birth trauma
timeFrame: Day 5
measure: neonatal intracranial or subgaleal hemorrhage
timeFrame: Day 5
measure: neonatal arterial hypotensio
timeFrame: day 1
measure: Maternal Postpartum Depression
timeFrame: 2 months after delivery.
measure: Posttraumatic Stress Disorder (PTSD)
timeFrame: 2 months after delivery.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: