Prelabor Rupture of MembranesPhase 4NCT05430711
Dinoprostone Induction vs. Expectant Management After PROM at Term
A Phase 4 study testing Dinoprostone in people with Prelabor Rupture of Membranes, run by University Medical Centre Ljubljana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Prelabor Rupture of Membranes
- What is being tested?
- Dinoprostone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prelabor Rupture of Membranes
- Being tested
- Dinoprostone
- Keywords
- Induction of labour, Dinoprostone, Cervical ripening
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinoprostoneDrug
Also called Propess
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.
| Study group | Role | What they receive |
|---|---|---|
| Dinoprostone | Experimental | Participants will receive dinoprostone 10 mg vaginal delivery system for up to 24 hours. Receives: Drug: Dinoprostone |
| Expectant management | No intervention | Participants will not receive drugs to induce labour, they will be managed expectantly for up to 24 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomisation to delivery
Time measured from randomisation to the delivery time
Measured: Within 1 week
Secondary outcomes (16)
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)
Measured: Within 1 week
Time from PROM to delivery
Time measured from prelabor rupture of membrane (leaking of amniotic fluid) until delivery
Measured: Within 1 week
Cesarean delivery rate
Percentage of patients who deliver via cesarean section for whatever reason
Measured: Within 1 week
Instrumental delivery rate
Percentage of patients who deliver via instrumental delivery (forceps, a vacuum device) for whatever reason
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.)
Measured: Within 3 weeks
Rate of postpartum maternal fever
A fever of 38.0°C or more in the postpartum period.
Measured: 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.
Measured: 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).
Measured: 3 weeks
Number of neonates, admitted to intensive care unit
Infants which will be admitted to the neonatal intensive unit for whatever reason.
Measured: 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.
Measured: Within 1 week
Maternal Length of Stay
Total length of hospitalization of women in days.
Measured: 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.
Measured: 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.
Measured: Within 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prelabor Rupture of MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polona Peclin, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430711
- Sponsor's protocol ID
- 0120-115/2019/13
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available on request
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labour With Dinoprostone vs. Expectant Management After Prelabour Rupture of Membranes at Term
- ClinicalTrials.gov ID
- NCT05430711
- Acronym / sponsor ID
- 0120-115/2019/13
- Conditions
- Prelabor Rupture of Membranes
- Keywords
- Induction of labour, Dinoprostone, Cervical ripening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dinoprostone | Experimental | Drug: DinoprostoneParticipants will receive dinoprostone 10 mg vaginal delivery system for up to 24 hours. |
| Expectant management | No intervention | –Participants will not receive drugs to induce labour, they will be managed expectantly for up to 24 hours. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 4 to12 hours after prelabour rupture of membranes
- 18-50 years of age
- Parity 0 to 2
- Singleton pregnancy
- Cephalic presentation
Key exclusion criteria (8 listed)
- Uterine contractions
- Signs of infection
- Signs of non-reassuring fetal status
- Meconium-stained amniotic fluid
- Group B Streptococcus colonization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DinoprostoneAlso: PropessAfter 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. | Drug | Dinoprostone |
Primary outcome
Time from randomisation to delivery
Time frame: Within 1 week
Time measured from randomisation to the delivery time
16 secondary outcomes
Time from randomisation to spontaneous vaginal delivery
Time frame: Within 1 week
Time from PROM to delivery
Time frame: Within 1 week
Cesarean delivery rate
Time frame: Within 1 week
Instrumental delivery rate
Time frame: Within 1 week
Use of oxytocin
Time frame: Within 1 week
Hyperstimulation with nonreassuring fetal heart rate tracing
Time frame: Within 1 week
Rate of chorioamnionitis
Time frame: Within 1 week
Rate of endometritis
Time frame: Within 3 weeks
Rate of postpartum maternal fever
Time frame: Within 3 weeks
Use of antibiotics
Time frame: Within 3 weeks
Lenght of antibiotic treatment
Time frame: 3 weeks
Number of neonates, admitted to intensive care unit
Time frame: Within 3 weeks
APGAR scores
Time frame: Within 1 week
Maternal Length of Stay
Time frame: Within 3 weeks
Rate of early neonatal sepsis
Time frame: Within 3 weeks
Patients perception of labor (length, pain, overall satisfaction)
Time frame: Within 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No. IPD will be available on request
Related trials for Prelabor Rupture of Membranes
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Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
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Not yet recruitingObservational study
Preterm Parturation Study
Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Not yet recruitingObservational study
Prediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes
Preterm Prelabor Rupture of Membranes (PPROM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dinoprostone in people with Prelabor Rupture of Membranes, run by University Medical Centre Ljubljana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Polona Pečlin (0038615526162, polona.peclin@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomisation to delivery (time frame: Within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.