Dinoprostone Induction vs. Expectant Management After PROM at Term
Primary Purpose
Prelabor Rupture of Membranes
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dinoprostone
Sponsored by
About this trial
This is an interventional treatment trial for Prelabor Rupture of Membranes focused on measuring Induction of labour, Dinoprostone, Cervical ripening
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dinoprostone
Expectant management
Arm Description
Participants will receive dinoprostone 10 mg vaginal delivery system for up to 24 hours.
Participants will not receive drugs to induce labour, they will be managed expectantly for up to 24 hours.
Outcomes
Primary Outcome Measures
Time from randomisation to delivery
Time measured from randomisation to the delivery time
Secondary Outcome Measures
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)
Time from PROM to delivery
Time measured from prelabor rupture of membrane (leaking of amniotic fluid) until delivery
Cesarean delivery rate
Percentage of patients who deliver via cesarean section for whatever reason
Instrumental delivery rate
Percentage of patients who deliver via instrumental delivery (forceps, a vacuum device) for whatever reason
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.
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.
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).
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.)
Rate of postpartum maternal fever
A fever of 38.0°C or more in the postpartum period.
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.
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).
Number of neonates, admitted to intensive care unit
Infants which will be admitted to the neonatal intensive unit for whatever reason.
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.
Maternal Length of Stay
Total length of hospitalization of women in days.
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.
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.
Full Information
NCT ID
NCT05430711
First Posted
June 11, 2022
Last Updated
June 18, 2022
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT05430711
Brief Title
Dinoprostone Induction vs. Expectant Management After PROM at Term
Official Title
Induction of Labour With Dinoprostone vs. Expectant Management After Prelabour Rupture of Membranes at Term
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prelabor Rupture of Membranes
Keywords
Induction of labour, Dinoprostone, Cervical ripening
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dinoprostone
Arm Type
Experimental
Arm Description
Participants will receive dinoprostone 10 mg vaginal delivery system for up to 24 hours.
Arm Title
Expectant management
Arm Type
No Intervention
Arm Description
Participants will not receive drugs to induce labour, they will be managed expectantly for up to 24 hours.
Intervention Type
Drug
Intervention Name(s)
Dinoprostone
Other Intervention Name(s)
Propess
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time from randomisation to delivery
Description
Time measured from randomisation to the delivery time
Time Frame
Within 1 week
Secondary Outcome Measure Information:
Title
Time from randomisation to spontaneous vaginal delivery
Description
Time measured from randomisation to the spontaneous vaginal delivery (delivery without the use of forceps, vacuum extraction, or a cesarean section)
Time Frame
Within 1 week
Title
Time from PROM to delivery
Description
Time measured from prelabor rupture of membrane (leaking of amniotic fluid) until delivery
Time Frame
Within 1 week
Title
Cesarean delivery rate
Description
Percentage of patients who deliver via cesarean section for whatever reason
Time Frame
Within 1 week
Title
Instrumental delivery rate
Description
Percentage of patients who deliver via instrumental delivery (forceps, a vacuum device) for whatever reason
Time Frame
Within 1 week
Title
Use of oxytocin
Description
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.
Time Frame
Within 1 week
Title
Hyperstimulation with nonreassuring fetal heart rate tracing
Description
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.
Time Frame
Within 1 week
Title
Rate of chorioamnionitis
Description
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).
Time Frame
Within 1 week
Title
Rate of endometritis
Description
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.)
Time Frame
Within 3 weeks
Title
Rate of postpartum maternal fever
Description
A fever of 38.0°C or more in the postpartum period.
Time Frame
Within 3 weeks
Title
Use of antibiotics
Description
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.
Time Frame
Within 3 weeks
Title
Lenght of antibiotic treatment
Description
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).
Time Frame
3 weeks
Title
Number of neonates, admitted to intensive care unit
Description
Infants which will be admitted to the neonatal intensive unit for whatever reason.
Time Frame
Within 3 weeks
Title
APGAR scores
Description
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.
Time Frame
Within 1 week
Title
Maternal Length of Stay
Description
Total length of hospitalization of women in days.
Time Frame
Within 3 weeks
Title
Rate of early neonatal sepsis
Description
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.
Time Frame
Within 3 weeks
Title
Patients perception of labor (length, pain, overall satisfaction)
Description
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.
Time Frame
Within 3 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Polona Pečlin
Phone
0038615526162
Email
polona.peclin@kclj.si
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available on request
Learn more about this trial
Dinoprostone Induction vs. Expectant Management After PROM at Term
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