Dinoprostone Induction vs. Expectant Management After PROM at Term

Induction of Labour With Dinoprostone vs. Expectant Management After Prelabour Rupture of Membranes at Term

Prelabour rupture of membranes (PROM) is associated with intrauterine infection and maternal and neonatal consequences. This risk increases with the length of time from PROM to delivery. Induction of labor has been shown to reduce the rates of those complications, however the optimal time interval has not yet been determined.

The main purpose of this single-center randomized prospective study is to assess the differences between two approaches of managing PROM at term-expectant management and induction with a dinoprostone vaginal delivery system.

Study Overview

• Status: Not yet recruiting
• Conditions: Prelabor Rupture of Membranes
• Intervention / Treatment: Drug: Dinoprostone

Detailed Description

Women with singleton pregnancy in cephalic presentation at term (37-41 6/7 weeks gestational age) will be randomised 4 to 12 hours after PROM when a sterile vaginal exam will be completed to assign Bishop score. When Bishop score at presentation will be ≤5, the study will be presented to the patient. Once the patient will be consented and randomized, women will receive dinoprostone vaginal delivery system (for up to 24 hours after randomisation) or will be managed expectantly (for up to 24 hours after randomisation).

Patients randomized to the expectant management group will be admitted to the maternity ward, where they will wait up to a maximum of 24 hours for labor to start spontaneously.

Patients in the induction group will also be admitted to the maternity ward and induced with a dinoprostone vaginal delivery system. If not removed sooner, the vaginal delivery system will be removed after 24h.

If patients in both groups will not be in active labor 24 hours after randomisation they will be admitted to the delivery room and health care providers will manage active labor per usual practice. The need for cesarean section or operative delivery or will be at the discretion of the healthcare provider.

In the days following birth, woman in both groups, will be asked to fill in a questionnaire about their satisfaction with the labour experience.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Polona Pečlin; Phone Number: 0038615526162; Email: polona.peclin@kclj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 4 to12 hours after prelabour rupture of membranes
• 18-50 years of age
• Parity 0 to 2
• Singleton pregnancy
• Cephalic presentation
• Term (37-41 6/7 weeks gestational age)
• Bishop score ≤5
• Reassuring fetal status

Exclusion Criteria:

• Uterine contractions
• Signs of infection
• Signs of non-reassuring fetal status
• Meconium-stained amniotic fluid
• Group B Streptococcus colonization
• Fetal demise or major congenital anomaly
• Intrauterine growth restriction (estimated fetal weight ≤ 3 percentile)
• Contraindications for vaginal birth or use of prostaglandins for labor induction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dinoprostone; Participants will receive dinoprostone 10 mg vaginal delivery system for up to 24 hours.	Drug: Dinoprostone; After randomization, participants will receive dinoprostone 10 mg vaginal delivery system which will remain in place up to 24 hours or until the labour begins. At the onset of labor or after 24h it will be removed and participant transferred to labour room for further standard procedures.; Other Names: Propess
NO_INTERVENTION: Expectant management; Participants will not receive drugs to induce labour, they will be managed expectantly for up to 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from randomisation to delivery	Time measured from randomisation to the delivery time	Within 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from randomisation to spontaneous vaginal delivery	Time measured from randomisation to the spontaneous vaginal delivery (delivery without the use of forceps, vacuum extraction, or a cesarean section)	Within 1 week
Time from PROM to delivery	Time measured from prelabor rupture of membrane (leaking of amniotic fluid) until delivery	Within 1 week
Cesarean delivery rate	Percentage of patients who deliver via cesarean section for whatever reason	Within 1 week
Instrumental delivery rate	Percentage of patients who deliver via instrumental delivery (forceps, a vacuum device) for whatever reason	Within 1 week
Use of oxytocin	Oxytocin used prior to the delivery of the baby. If oxytocin was used, we will measure how many international units (IU) of oxytocin were used from the beginning of labor to the delivery of the baby.	Within 1 week
Hyperstimulation with nonreassuring fetal heart rate tracing	Percentage of uterine hyperstimulation- exaggerated uterine response consisting of uterine hypertonus, a single uterine contraction lasting two or more minutes or uterine tachysystole with a least 12 contractions in 20 minutes, with a simultaneous nonreassuring fetal heart rate tracing as defined by the 2015 FIGO (The international federation of gynaecology and obstetrics) classification of intrapartum cardiotocography.	Within 1 week
Rate of chorioamnionitis	Clinical chorioamnionitis (a fever of 38.0°C or more plus one or more of the following: baseline fetal heart rate > 160 beats/minute for ≥ 10 minutes, maternal white cell count >15,000 cells/mm3 or purulent-appearing fluid coming from the cervical os visualized by speculum examination).	Within 1 week
Rate of endometritis	Clinical endometritis (postpartum woman with at least two of the following signs or symptoms: fever ≥38.0°C, pain or tenderness (uterine or abdominal) with no other recognized cause or purulent drainage from the uterus.)	Within 3 weeks
Rate of postpartum maternal fever	A fever of 38.0°C or more in the postpartum period.	Within 3 weeks
Use of antibiotics	Possible use of antibiotics in the postpartum period.The decision of the need of antibiotics in the postpartum period is in the discretion of the physician.	Within 3 weeks
Lenght of antibiotic treatment	The decision of the need of antibiotics in the postpartum period is in the discretion of the physician. If antibiotics will be used, we will measure length of antibiotic treatment (in days).	3 weeks
Number of neonates, admitted to intensive care unit	Infants which will be admitted to the neonatal intensive unit for whatever reason.	Within 3 weeks
APGAR scores	Infants with a 5-minute APGAR score of less than 7.The Apgar score is a number calculated by scoring the heart rate, respiratory effort, muscle tone, skin color, and reflex irritability of the infant, 5 min after birth. Each of these objective signs can receive 0, 1, or 2 points. The higher is the sum of the points, the better is the condition of the newborn.	Within 1 week
Maternal Length of Stay	Total length of hospitalization of women in days.	Within 3 weeks
Rate of early neonatal sepsis	Infants with early neonatal sepsis, a diagnosis based on a positive blood, cerebrospinal fluid, or urine microbiological culture in the first 72 hours after birth.	Within 3 weeks
Patients perception of labor (length, pain, overall satisfaction)	Satisfaction and perceptions of woman giving birth with labour through a self-administered questionnaire that they will answer in the postpartum period (6 to 48 hours after labor). They will specify their level of agreement or disagreement on a symmetric 4-point agree-disagree scale (1- I strongly disagree, 2- I disagree, 3- I agree, 4- I strongly agree) for a series of statements regarding aspects of birth. With the beforementioned scale we will measure patients' perception of length of hospitalization before childbirth, perception of pain before admission to the labour room, pain associated with vaginal examinations and insertion of the vaginal insert and if they would choose the same method of managing birth in the next pregnancy.	Within 3 weeks

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: June 11, 2022
• First Submitted That Met QC Criteria: June 18, 2022
• First Posted (ACTUAL): June 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 18, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cervical ripening; Induction of labour; Dinoprostone
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Rupture; Fetal Membranes, Premature Rupture; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: 0120-115/2019/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No