search
Back to results

Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor (GELFREQ)

Primary Purpose

Labor Complication, Cervix

Status
Completed
Phase
Phase 2
Locations
Martinique
Study Type
Interventional
Intervention
Dinoprostone vaginal gel
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Complication focused on measuring Induction, Term, Labor, Rhythm, Prostaglandins

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients above 18 years
  • Gestational age ≥ 37 weeks
  • With indicated induction of labor and initial Bishop score under 6
  • Without any contraindication to vaginal delivery
  • Who consent to participate to the clinical research
  • With French Medical Public Insurance

Exclusion Criteria:

  • Multiple pregnancy
  • Previous uterine scar (for myomas or cesarean section)
  • Fetus not in cephalic presentation
  • Allergy to prostaglandins
  • Who not consent to participate to the study

Sites / Locations

  • University Hospital of Martinique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Classical administration

Experimental administration

Arm Description

One prostaglandin vaginal gel every 24 hours

One prostaglandin vaginal gel every 12 hours

Outcomes

Primary Outcome Measures

Time between gel administration and delivery
Time between first gel administration for cervical priming and delivery
Time between gel administration and delivery
Change between cervical priming and delivery
Time between gel administration and delivery
Time between first gel administration for cervical priming and delivery
Time between gel administration and delivery
Time between first gel administration for cervical priming and delivery

Secondary Outcome Measures

Maternal satisfaction
maternal satisfaction measured by survey self-administered during postpartum hospital stay
Cesarean section rate
Hypertonia / hypercinesia rate
Hypertonia (rise of uterus tone more than 10 minutes)/hypercinesia (more than 5 uterine contractions per 10 minutes) rate during priming and induction
Oxytocin dose during labor
Induction or augmentation of Oxytocin doses
Length of active first phase of labor
Induction or augmentation of active first phase of labor
Maternal morbidity
Fever during labor, perineal laceration superior to 2nd degree, postpartum hemorrhage, endometritis
Neonatal immediate morbidity
Assess if Apgar score is less than 7
Neonatal immediate morbidity
Assess of arterial cord pH level
Neonatal immediate morbidity
Assess of arterial cord lactate level
Neonatal immediate morbidity
Concentration of arterial cord lactates level (in Mmol/L)
Neonatal immediate morbidity
Occurence or not of resuscitation maneuvers in delivery room
Neonatal immediate morbidity
Occurence or no transfer of the child to neonatal intensive care unit

Full Information

First Posted
April 7, 2020
Last Updated
July 18, 2023
Sponsor
University Hospital Center of Martinique
search

1. Study Identification

Unique Protocol Identification Number
NCT04413890
Brief Title
Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor
Acronym
GELFREQ
Official Title
Administration of Prostaglandin Gel for Cervical Priming During Induction of Labour Every 12 Hours Versus 24 Hours: a Randomized Superiority Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study compares two rhythms of administration of prostaglandin vaginal gels for cervical priming before induction of labor in term patients. In our institution, prostaglandin gels are given for a maximum of three times, with induction by oxytocin and amniotomy the day after the last gel whatever Bishop score has been obtained. This management results in some patient spending four days in hospital before delivery. The aim of the study is to compare our classical management scheme with a reduced interval between to gels, of 12h instead of 24 h. The primary outcome will be the time elapsed between the first prostaglandin gel and delivery. Tolerance of both management patterns will also be evaluated through a satisfaction survey.
Detailed Description
Approximatively 22% of pregnant women have an induction of labor in France (22.9% in our institution in 2019), mainly for prolonged pregnancy after 41 weeks gestational age or prolonged rupture of membranes. Patients whose cervix is considered unripe (Bishop score under 6) are generally proposed a cervical priming because induction of labor without prior priming entails a higher of cesarean delivery rate for failed induction. The devices used for cervical priming are pharmacological (mainly prostaglandin gel, pessaries or suppositories) or mechanical (Foley catheter, Cook balloons). Very few recommendations exist regarding the type of device, the rhythm and maximal number of repeat administrations and the interval between two administrations. Shortening interval between two administrations (in case of use of a device necessitating serial prescriptions) may shorten the time interval between beginning of priming and delivery. In our institution, a vaginal gel can be given three times before induction of labor with oxytocin and amniotomy, whatever Bishop score has been obtained after priming. These gels are given on a daily basis. This rhythm implies than for some women not responding to a first gel, priming can last up to three days, lengthening hospital stay and leading to maternal weariness. Maternal satisfaction during induction of labor is seldom analyzed. An intensification in gel administration implies a change in maternal management during the induction process, with shortened periods of rest between two gels and nearer periods of pain and discomfort, albeit on a theoretically shorter period. The way patients deal with this new rhythm compared to the classical in part of the evaluation in this study. All patients having a singleton pregnancy and an indication for term (≥ 37 weeks gestation age) induction with an unfavorable cervix and no contraindication to vaginal delivery will be eligible. Patients with fetuses in breech presentation, a scarred uterus, under 18 years, bearing a fetus with antenatally known malformation, not fluent in French or presenting an allergy to prostaglandins will be excluded. A written informed consent will be required before inclusion. The primary outcome will be the duration between first priming with prostaglandin gel and delivery. Secondary outcomes will be the satisfaction of patients with their induction process (measured through a survey answered during the in-hospital post-partum stay), the rate of cesarean section, the rate of hypertonia/hypercinesia during priming and induction requiring medical intervention, the length of active phase of labor (after 5 cm of dilation), the oxytocin doses used during delivery for induction or augmentation, initial neonatal (Apgar score, arterial cord pH and lactates, resuscitation maneuvers, transfer to intensive care unit) and maternal (post-partum hemorrhage, hyperthermia during labor, perineal laceration > 2nd degree and endometritis) morbidity and length of total hospital stay. The investigators calculated that a sample of 268 patients (134 in each group) will be necessary to detect a 30% reduction in duration between first priming and delivery in the experimental group (one gel every 12h) compared with the classical group. Mean time frame between first priming and delivery has been measured in our department in 2018 to 31.8 hours (standard deviation 27.6 hours).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication, Cervix
Keywords
Induction, Term, Labor, Rhythm, Prostaglandins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Classical administration
Arm Type
Active Comparator
Arm Description
One prostaglandin vaginal gel every 24 hours
Arm Title
Experimental administration
Arm Type
Experimental
Arm Description
One prostaglandin vaginal gel every 12 hours
Intervention Type
Drug
Intervention Name(s)
Dinoprostone vaginal gel
Other Intervention Name(s)
cervical priming with prostaglandin gel
Intervention Description
Prostaglandin gel 0.5, 1 or 2 mg
Primary Outcome Measure Information:
Title
Time between gel administration and delivery
Description
Time between first gel administration for cervical priming and delivery
Time Frame
At inclusion (Day 0)
Title
Time between gel administration and delivery
Description
Change between cervical priming and delivery
Time Frame
At 12 hours or 24 hours (after each gel administration)
Title
Time between gel administration and delivery
Description
Time between first gel administration for cervical priming and delivery
Time Frame
Time 0 after the childbirth
Title
Time between gel administration and delivery
Description
Time between first gel administration for cervical priming and delivery
Time Frame
Until 5 days postpartum (during in-hospital postpartum period)
Secondary Outcome Measure Information:
Title
Maternal satisfaction
Description
maternal satisfaction measured by survey self-administered during postpartum hospital stay
Time Frame
Until 5 days postpartum
Title
Cesarean section rate
Time Frame
During labor
Title
Hypertonia / hypercinesia rate
Description
Hypertonia (rise of uterus tone more than 10 minutes)/hypercinesia (more than 5 uterine contractions per 10 minutes) rate during priming and induction
Time Frame
During priming and induction
Title
Oxytocin dose during labor
Description
Induction or augmentation of Oxytocin doses
Time Frame
During labor
Title
Length of active first phase of labor
Description
Induction or augmentation of active first phase of labor
Time Frame
During labor
Title
Maternal morbidity
Description
Fever during labor, perineal laceration superior to 2nd degree, postpartum hemorrhage, endometritis
Time Frame
During labor
Title
Neonatal immediate morbidity
Description
Assess if Apgar score is less than 7
Time Frame
5 minutes after childbirth
Title
Neonatal immediate morbidity
Description
Assess of arterial cord pH level
Time Frame
5 minutes after childbirth
Title
Neonatal immediate morbidity
Description
Assess of arterial cord lactate level
Time Frame
5 minutes after childbirth
Title
Neonatal immediate morbidity
Description
Concentration of arterial cord lactates level (in Mmol/L)
Time Frame
5 minutes after childbirth
Title
Neonatal immediate morbidity
Description
Occurence or not of resuscitation maneuvers in delivery room
Time Frame
5 minutes after childbirth
Title
Neonatal immediate morbidity
Description
Occurence or no transfer of the child to neonatal intensive care unit
Time Frame
5 minutes after childbirth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients above 18 years Gestational age ≥ 37 weeks With indicated induction of labor and initial Bishop score under 6 Without any contraindication to vaginal delivery Who consent to participate to the clinical research With French Medical Public Insurance Exclusion Criteria: Multiple pregnancy Previous uterine scar (for myomas or cesarean section) Fetus not in cephalic presentation Allergy to prostaglandins Who not consent to participate to the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc VOLUMENIE
Organizational Affiliation
University Hospital of Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor

We'll reach out to this number within 24 hrs