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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
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    June 11, 2022
    Last Updated
    June 18, 2022
    Sponsor
    University Medical Centre Ljubljana
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    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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