Labour InductionRCTNCT04514770
Impact of Early Versus Late Amniotomy on Labour Induction in Nulliparous Women After Vaginal Misoprostol
A study testing Misoprostol in people with Labour Induction, run by Menoufia University at 1 site in Egypt.
Trial summary
Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor. Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Induction
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2019to 20 Mar 2020
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women at 36 weeks gestation or more
- Nullipara
- singleton fetus
- cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.
Who cannot join
- Macrocosmic babies with estimated fetal weight of more than 4000 gram
- Previous uterine scars
- Pre labor premature rupture of fetal membranes
- Polyhydramnios.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Late Amniotomy on Labour Induction in Nulliparous Women
Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.
Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable
Read the detailed description
study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020
- Conditions
- Labour Induction
- Being tested
- Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Amniotomy
rupture of membrane early and late
| Study group | Role | What they receive |
|---|---|---|
| early amniotomy | Active comparator | Group A:
1. Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached.
2. Early amniotomy was performed for the participant of the first group at 3 cementer cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. Receives: Drug: Misoprostol |
| Late amniotomy | Active comparator | Group B:
1. Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached.
2. late amniotomy was performed for the participant of the second group at 7 cementer cervical dilatation. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful induction
definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction
Measured: immediately after intervention
induction-delivery interval
duration of labor and amniotomy delivery interval
Measured: immediately after intervention
Secondary outcomes (5)
misoprostol doses administered
number of misoprostol doses administered
Measured: during the intervention
the need for augmentation of labor
the need for augmentation of labor by oxytocin and perinatal outcomes included cord prolapse and abnormal FHR changes during labor
Measured: during the intervention
intrapartum meconium
intrapartum meconium passage
Measured: during the intervention
Apgar score
Apgar score less than 7 at 1 and 5 minutes
Measured: during the intervention
newborn admission in the neonatal intensive care unit
newborn admission in the neonatal intensive care unit (NICU).
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start3 May 2019
- Primary completion10 Jan 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour InductionStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Model description
- Group A: Early amniotomy was performed for the participant of the first group at 3 cm cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. Group B: late amniotomy was performed for the participant of the second group at 7 cm cervical dilatation.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsibai Anter, Menoufia Obstetrics and Gynecology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514770
- Sponsor's protocol ID
- 11/2019 OBSGN 27
- Acronym
- RCT
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Amniotomy on Labour Induction in Nulliparous Women
- ClinicalTrials.gov ID
- NCT04514770
- Acronym / sponsor ID
- RCT / 11/2019 OBSGN 27
- Conditions
- Labour Induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 17 Aug 2020 (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.
Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.
Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable
Detailed description
study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: Early amniotomy was performed for the participant of the first group at 3 cm cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. Group B: late amniotomy was performed for the participant of the second group at 7 cm cervical dilatation.
| Arm | Type | Receives |
|---|---|---|
| early amniotomy | Active comparator | Drug: MisoprostolGroup A: 1. Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached. 2. Early amniotomy was performed for the participant of the first group at 3 cementer cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. |
| Late amniotomy | Active comparator | Drug: MisoprostolGroup B: 1. Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached. 2. late amniotomy was performed for the participant of the second group at 7 cementer cervical dilatation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women at 36 weeks gestation or more
- Nullipara
- singleton fetus
- cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.
Key exclusion criteria (4 listed)
- Macrocosmic babies with estimated fetal weight of more than 4000 gram
- Previous uterine scars
- Pre labor premature rupture of fetal membranes
- Polyhydramnios.
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 |
|---|---|---|
| MisoprostolAlso: Amniotomyrupture of membrane early and late | Drug | Late amniotomy, early amniotomy |
Primary outcome
successful induction
Time frame: immediately after intervention
definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction
induction-delivery interval
Time frame: immediately after intervention
duration of labor and amniotomy delivery interval
5 secondary outcomes
misoprostol doses administered
Time frame: during the intervention
the need for augmentation of labor
Time frame: during the intervention
intrapartum meconium
Time frame: during the intervention
Apgar score
Time frame: during the intervention
newborn admission in the neonatal intensive care unit
Time frame: immediately after intervention
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 17 Aug 2020.
- Individual participant dataSharing planned: No
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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 Misoprostol in people with Labour Induction, run by Menoufia University at 1 site in Egypt.
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 4 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 17 Aug 2020. 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 Egypt. 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?
successful induction (time frame: immediately after intervention). The study lists 2 primary outcomes in all. 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 17 Aug 2020.