DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies

Not Applicable

Recruiting

• Conditions: Induction of Labor
• Interventions: Drug: Dinoprostone 10mg (Propess); Device: Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening

• Registration Number: NCT04747301
• Lead Sponsor: Hanoi Obstetrics and Gynecology Hospital

Brief Summary

To compare the effectiveness and safety of double balloon catheter and vaginal insert Prostaglandin E2 in cervical ripening prior to Induction of Labor in low-risk women from 39+0 to 40+6 weeks of gestation.

Detailed Description

Induction of labor (IOL) is a technique to establish vaginal delivery when the risks for continuing the pregnancy for mother or baby are higher than the risks of delivery. In case the cervix is unripe, cervical ripening before the onset of labor is needed. The two main mechanisms of cervical ripening can be categorized as mechanical or pharmacological.

A Cochrane systematic review and other recent meta-analysis have shown that cervical ripening with a balloon is probably as effective as induction of labor with vaginal Prostaglandin E2. However, this conclusion is based on low to moderate quality evidence. Only a limited number of randomized clinical trials (RCTs) have been conducted. Many of those suffering from small sample sizes and different study subjects, i.e. high-risk subjects only, and mixed population.

In current practice, induction of labor is not only used in high-risk patients with clear indications for pregnancy termination. The ARRIVE trial has shown a significant benefit of labor induction over expectant management among the low-risk population. Based on this evidence, the American College of Obstetricians and Gynecologists (ACOG) has suggested: "It's time to induce of labor at 39th week of gestation". Since then, there is a trend in favoring elective induction before the due date over expectant management. Besides, more and more pregnant women want to shorten the duration of pregnancy or to time the birth of the baby due to the convenience of the mother and/or healthcare workers.

This makes the optimal method of Induction of Labor in terms of effectiveness and safety for both mothers and their babies even more important. In this study, the investigators will compare the effectiveness and safety of double-balloon catheter and Prostaglandin E2 for elective labor induction in low-risk pregnancies.

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

1. Maternal age ≥ 18
2. Singleton pregnancy. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks gestational age.
3. Gestational age at randomization from at 39+0 to 40+6 weeks of gestation.
4. Cephalic presentation
5. Intact membrane
6. Unfavourable cervix (Bishop<6)
7. Informed consent

Exclusion Criteria

1. Maternal medical illness associated with increased risk of adverse pregnancy outcome (any diabetes mellitus, any hypertensive disorders, cardiac diseases, renal insufficiency, systemic lupus erythematosus, mental disorders, HIV positive, use of heparin or low-molecular weight heparin during the current pregnancy etc.)

2. Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa

3. Abnormal amniotic fluid volume:

   • Oligohydramnios (MVP < 2cm)
   • Polyhydramnios (MVP > 10cm)

4. Abnormal fetus

   • Fetal demise or known major fetal anomalies
   • Fetal growth restriction (FGR) (EFW < 3% or < 10% and abnormal Doppler)
   • Non-reassuring fetal status (no fetal movements, abnormal fetal heart rate at auscultation)

5. Previous C-section

6. Planned for C-section or contra-indication to labour

7. Cerclage or use of pessary in current pregnancy

8. Refusal of blood product.

9. Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal insertion Prostaglandin E2 group	Dinoprostone 10mg (Propess)	Propess® 10mg Vaginal delivery system (Ferring Controlled Therapeutics Ltd., 1 Redwood Place, Peel Park Campus, East Kilbride, Glasgow, G74 5PB, UK) is a vaginal insert containing 10mg of dinoprostone in a timed-release formulation (the medication is released at 0.3 mg/hour).
Double-balloon catheter group	Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening	Sweeping the membranes by UTAH CVX-RIPE® (Utah Medical Products, Inc, 7043 South 300 West, Midvale, Utah 84047 USA).

Primary Outcome Measures

Name	Time	Method
Number of participants delivered vaginally	From randomization until delivery, assessed up to 3 days after randomization	Number of participants delivered vaginally

Secondary Outcome Measures

Name	Time	Method
Number of participants with Side - effect of induction's method	From induction until delivery, assessed up to 3 days after induction	Including any of: nausea, vomiting, diarrhea, pain...
Number of participants having oxytocin augmentation	From induction until delivery, assessed up to 3 days after induction	Number of participants having oxytocin augmentation
Number of participants with uterine tachysystole	From induction until delivery, assessed up to 3 days after induction	Defined as more than 5 contractions in 10 minutes over a minimal period of two times 10 minutes with Fetal Heart Rate changes and/or a contraction lasting more than 3 minutes with Fetal Heart Rate changes.
Time from induction of labor to delivery	From induction until delivery, assessed up to 3 days after induction	Duration from induction to delivery (hours)
Number of participants delivered vaginally within 24 hours	Within 24 hours from labor induction	Number of participants delivered vaginally within 24 hours
Number of participants with post-partum haemorrhage	Within 24 hours from delivery	Defined as blood loss \>500 ml at vaginal birth or \>1000 ml at caesarean birth within 24 hours after birth
Number of participants having uterine atony	From delivery until maternal hospital discharge, assessed up to 28 days after delivery	Use of two or more uterotonics other than oxytocin; other surgical interventions such as uterine compression by hands and/or sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade).
Number of participants having maternal post-partum blood transfusion	From delivery until maternal hospital discharge, assessed up to 28 days after delivery	Number of participants having maternal post-partum blood transfusion
Number of participants with hypertension complications	From randomization until maternal hospital discharge, assessed up to 28 days after randomization	Number of participants with hypertension complications
Number of participants with uterine dehiscence or rupture	From delivery until maternal hospital discharge, assessed up to 28 days after delivery	Uterine dehiscence (defined as clinically asymptomatic disruption of the uterus that is discovered incidentally at surgery) or rupture (defined as clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair)
Number of participants with maternal infection	From induction until maternal hospital discharge, assessed up to 28 days after induction	* Fever (defined as a temperature ≥37.5 degrees Celsius); * Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation); * Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture)
Number of participants with hysterectomy	From delivery until maternal hospital discharge, assessed up to 28 days after delivery	Hysterectomy for any postpartum complications
Number of participants with damage to internal organs	From delivery until maternal hospital discharge, assessed up to 28 days after delivery	Including intestines, bladder or ureters
Number of participants with other post-partum complications	From randomization until maternal hospital discharge, assessed up to 28 days after randomization	Includes: venous embolism, pulmonary embolism, stroke, cardiac arrest
Number of participants admitted to intensive care unit	From randomization until maternal hospital discharge, assessed up to 28 days after randomization	Number of participants admitted to intensive care unit
Number of maternal death among participants	From randomization until maternal hospital discharge, assessed up to 28 days after randomization	Maternal death from randomization through hospital discharge
Number of participants referred to other hospital due to severe morbidities	From randomization until maternal hospital referral, assessed up to 28 days after randomization	Including: pulmonary embolus, stroke, cardiorespiratory arrest, etc.
Maternal length of stay	From admission until maternal hospital discharge, assessed up to 28 days after admission	Duration of stay in hospital (days)
Number of Infants with Apgar Score ≤7 at 1 and 5 minutes	Assessed at 1 and 5 minute after birth	Infants with Apgar Score ≤7 at 1 and 5 minutes
Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit	From delivery until admission to Neonatal Intensive Care Unit or Intermediate care unit, assessed up to 7 days after delivery	Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit
Number of participants using more than one induction agent required	From induction until delivery, assessed up to 3 days after induction	Number of participants using more than one induction agent required
Psychometric aspects	At admission (version A) and before maternal hospital discharge (version B), assessed up to 28 days after admission	Feelings and thoughts pregnant women at antepartum and postpartum will be evaluated by Wijma Delivery Expectancy/Experience Questionnaires' (W-DEQ) version A and version B, respectively, expected to be filled out in approximately 30 minutes; This is a questionnaire which measures a construct of fear related to childbirth during pregnancy and after delivery by asking the woman about her expectancies before delivery(version A) - performed at admission, and experiences after delivery (version B) - performed before maternal hospital discharge respectively.; When filling in the W-DEQ, the woman is instructed to rate her personal feelings and cognitions on a six-point scale. The minimum score is 0 and the maximum score is 126. The higher the score, the greater the fear of childbirth manifested.
Apgar scores at 1 and 5 minute	Assessed at 1 and 5 minute after birth	Apgar scores at 1 and 5 minute
Reason for Neonatal Intensive Care Unit admission	From delivery until Neonatal Intensive Care Unit admission, assessed up to 28 days after delivery	Reason for Neonatal Intensive Care Unit admission such as: respiratory distress, hypoglycemia, seizures, etc.
Length of stay at the Neonatal Intensive Care Unit or Intermediate care unit	From admission to Neonatal Intensive Care Unit/ Intermediate care unit until neonatal discharge or hospital referral, assessed up to 28 days after Neonatal Intensive Care Unit admission	Duration from admission to Neonatal Intensive Care Unit or Intermediate care unit to Neonatal Intensive Care Unit/ Intermediate care unit discharge or hospital referral
Number of neonates with birth trauma	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Include: bone fractures, traumatic pneumothorax, facial nerve palsy, other neurologic injury (Brachial plexus palsy...), etc.
Number of neonates with hypoglycemia	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Number of neonates with hypoglycemia
Number of neonates with jaundice and hyperbilirubinemia	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Number of neonates with jaundice and hyperbilirubinemia
Number of neonates with Hypoxic ischemic encephalopathy or need for therapeutic hypothermia	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Number of neonates with Hypoxic ischemic encephalopathy or need for therapeutic hypothermia
Number of neonates with meconium aspiration syndrome	From delivery until neonatal hospital discharge, assessed up to 07 days after delivery	Criteria include: * Meconium-stained amniotic fluid; * Respiratory distress at birth or shortly after birth; * Characteristic radiographic features: The initial chest film may show streaky, linear densities -\> the lungs typically appear hyper-inflated with flattening of the diaphragms.
Number of neonates in need for respiratory supports	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Incubation, Continuous Positive Airway Pressure, or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within the first 72 hours
Number of neonates with neonatal infection	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/supra-pubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an X-ray confirming infection
Number of neonates with neonatal seizures	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Number of neonates with neonatal seizures
Number of neonates with intracranial hemorrhage	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Intra-ventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma Subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Number of neonates need blood transfusion	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Number of neonates need blood transfusion
Number of neonatal deaths	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery	Includes: Intrapartum/neonatal/perinatal deaths
Number of neonates referred to other hospital for severe morbidities	From delivery until neonatal hospital referral, assessed up to 28 days after delivery	Number of neonates referred to other hospital for severe morbidities

Trial Locations

Locations (1)

Hanoi Obstetrics and Gynecology Hospital; 🇻🇳 Hanoi, Hà Nội, Vietnam