Labor, InducedNCT04731896
Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6
A study testing Amniotomy in people with Labor, Induced and Amniotomy, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth. A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Induced, Amniotomy
- What is being tested?
- Amniotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 8 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years old
- Full term (36 weeks and 3 days of gestation reached)
- Singletion gestation in cephalic presentation
- Bishop score of ≥ 6
Who cannot join
- Prior uterine surgery, previous cesarean section
- Ruptured membranes
- Spontaneous labor
- Multifetal pregnancy
- Dystocic presentation
- Fetal head not fixed at pelvic brim
Show all 13Show fewer
- Macrosomia
- Hydramnios
- Severe fetal growth restriction
- Major fetal anomaly
- Women with HIV, hepatitis C, hepatitis B
- Women with medical conditions contraindication to a vaginal delivery
- Women with COVID-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 : a Randomized Trial
Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth.
A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health.
Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown.
The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.
- Conditions
- Labor, Induced, Amniotomy
- Being tested
- Amniotomy
- Keywords
- labor, Amniotomy, induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmniotomyProcedure or surgery
artificial rupture of the amniotic sac
| Study group | Role | What they receive |
|---|---|---|
| Late Amniotomy | No intervention | Initiating induction of labor with oxytocin infusion followed by amniotomy 4-6 hours later |
| Early Amniotomy | Active comparator | Early amniotomy initiating induction of labor followed by oxytocin infusion 30 minutes later Receives: Procedure: Amniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to active phase of labor
Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation
Measured: At delivery
Secondary outcomes (4)
Cesarean delivery rate
Rate of cesarean section
Measured: At delivery
Time to vaginal delivery
Total time from initiation of labor induction to vaginal delivery
Measured: At delivery
Maternal outcomes
Intrapartum and postpartum fever, postpartum haemorrhage, chorioamnionitis, endometritis
Measured: From inclusion to discharge, up to 2 weeks
Fetal and neonatal outcome
Fetal distress, birth asphyxia, acidosis, sepsis
Measured: From inclusion to discharge, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start8 Feb 2021
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Halouani, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731896
- Sponsor's protocol ID
- UTuniselmanar2
- Status last verified
- Sep 2022
- First submitted
- 26 Jan 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 : a Randomized Trial
- ClinicalTrials.gov ID
- NCT04731896
- Acronym / sponsor ID
- UTuniselmanar2
- Conditions
- Labor, Induced, Amniotomy
- Keywords
- labor, Amniotomy, induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Feb 2021 (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.
Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth.
A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health.
Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown.
The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late Amniotomy | No intervention | –Initiating induction of labor with oxytocin infusion followed by amniotomy 4-6 hours later |
| Early Amniotomy | Active comparator | Procedure: AmniotomyEarly amniotomy initiating induction of labor followed by oxytocin infusion 30 minutes later |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Full term (36 weeks and 3 days of gestation reached)
- Singletion gestation in cephalic presentation
- Bishop score of ≥ 6
Key exclusion criteria (13 listed)
- Prior uterine surgery, previous cesarean section
- Ruptured membranes
- Spontaneous labor
- Multifetal pregnancy
- Dystocic presentation
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 |
|---|---|---|
| Amniotomyartificial rupture of the amniotic sac | Procedure or surgery | Early Amniotomy |
Primary outcome
Time to active phase of labor
Time frame: At delivery
Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation
4 secondary outcomes
Cesarean delivery rate
Time frame: At delivery
Time to vaginal delivery
Time frame: At delivery
Maternal outcomes
Time frame: From inclusion to discharge, up to 2 weeks
Fetal and neonatal outcome
Time frame: From inclusion to discharge, up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotomy in people with Labor, Induced and Amniotomy, run by University Tunis El Manar at 1 site in Tunisia.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to active phase of labor (time frame: At delivery). 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 28 Sep 2022.