Cervix; PregnancyPhase 1/2NCT05306405
Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream
A Phase 1/2 study testing Vaginal Tablet in people with Cervix; Pregnancy, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix; Pregnancy
- What is being tested?
- Vaginal Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to 30 Aug 2022
- Phase
- Phase 1/2
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age36:41 weeks.
- Singleton pregnancy.
- Absence of labour pain.
- Living fetus with cephalic presentation.
- Fetal weight < 4 k.gs.
- No previous uterine surgical procedures.
- No liquor abnormalities.
- Bishop score < 5.
Who cannot join
- - Multiple gestations. one of the contraindications of induction of labor as it may cause rupture of the uterus.
- Liquor abnormalities.one of contraindications of induction of labor as it may cause fetal distress.
- Abnormal umbilical artery Doppler indices or non-stress test as these indicate fetal distress.
- Fetal weight > 4 kgs.as macrosomia is an indication of caesarean section for fear of shoulder dystocia .
- Previous uterine surgery.contraindication of labor induction for fear of rupture uterus.
- Asthmatic patient or women with allergy to prostaglandins or steroidal.
Show all 9Show fewer
- Non-vertex presentation.contraindication of labor induction as it may cause rupture uterus.
- Fetal or maternal complications that might cause cesarean section.
- Intrauterine fetal death.often induction of labor in women with a dead fetus is performed before term when the uterus may be less responsive to uterotonics than it is at term and this will affect the results of the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
.Fekria A Salama, Professor, +201092934978, dr_amiramaher@yahoo.com
Mortada S Ahmed, Professor, +201001267054, Mortada.elsayed80@gmail.com
About this study
Official title: Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labour
To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix
Read the detailed description
Induction of labour (IOL) is the process of initiating contractions of pregnant persons who are currently not in labour, to help them achieve vaginal delivery within 24 to 48 hours. Cervical ripening is one of the methods that used for labour induction; it is "the use of pharmacological or other means to soften, efface, or dilate the cervix to increase the likelihood of a vaginal delivery". The two major techniques for cervical ripening are mechanical interventions (e.g. insertion of balloon catheters), and application of pharmacological agents (e.g. prostaglandins). Prostaglandins are one of the preferred methods for cervical ripening, including the agents dinoprostone and misoprostol
. By the mid of-1980s prostaglandins had become established as the most effective pharmacological agents for inducing labour when the cervix is unripped. The vaginal route was found to be the most acceptable, providing good efficacy and acceptability for the parturient and it is the preferred choice now.
During the past 15 years the introduction of misoprostol, the prostaglandinsE1(PGE1) which, unlike prostglandinsE2 (PGE2), is stable at room temperature and it is effective if it was taken orally, has been the major focus of attention for labour induction. It is also considerably cheaper than the alternative prostaglandin.
With the ever-increasing concentrations of estrogen in the maternal circulation leading to term pregnancy, the belief that this could be a trigger for the onset of spontaneous labour led the studies to explore estrogens for the induction of labour.
Estradiol gel gives extra--amniotic, endocervical or vaginally or estradiol intramuscularly and estradiol gel extra-amniotic have been shown to produce some improved cervical favorability with minimal myometrial stimulation.
- Conditions
- Cervix; Pregnancy
- Being tested
- Vaginal Tablet
- Keywords
- cervical dilatation, Uneffaced cervix, closed os
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal TabletDrug
Also called vaginal misoprostol and vaginal estradiol
Misoprostol alone will be repeated every 4 h in both groups for a maximum of 5 doses, reaching Bishop score >8, rupture of membranes or occurrence of labor pain.
Cervical evaluation will be done using Bishop's score. A score < 5 will be taken as unfavorable Cervix will be termed as ripped when Bishop's score equal 8 or more.
The endpoint of the study will be initiation of active phase of 1st stage of labor which commence from 6cm to full cervical dilatation
| Study group | Role | What they receive |
|---|---|---|
| vaginal misoprostol | Active comparator | only vaginal misoprostol 25 μg tablets will be applied for induction of laour Receives: Drug: Vaginal Tablet |
| combined vaginal misoprostol and estradiol | Active comparator | vaginal misoprostol 25 μg (Vagiprost) tablets with vaginal estradiol 150 ml cream will be applied for induction of laour Receives: Drug: Vaginal Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of labour with closed cervix
assessment of uterine contractions and cervical opening of the pregnant females who are currently not in labour, to help them to reach normal vaginal delivery process.
Measured: from 0 hours to 14 hours after induction of labour
Secondary outcomes (1)
The Whole Delivery time after induction of labour.
The whole time from induction to the end of vaginal labour with complications that may arise as:
-uterine hyperstimulation, postpartum hemorrhage, rupture of the uterus and neonatal morbidity, fetal distress, and fetal hypoxia.
Measured: from 0 hours to the end of the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start20 Feb 2022
- Primary completion1 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix; PregnancyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Maher, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306405
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 1 Apr 2022
- 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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labour
- ClinicalTrials.gov ID
- NCT05306405
- Acronym / sponsor ID
- 001
- Conditions
- Cervix; Pregnancy
- Keywords
- cervical dilatation, Uneffaced cervix, closed os
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 1 Apr 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.
To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix
Detailed description
Induction of labour (IOL) is the process of initiating contractions of pregnant persons who are currently not in labour, to help them achieve vaginal delivery within 24 to 48 hours. Cervical ripening is one of the methods that used for labour induction; it is "the use of pharmacological or other means to soften, efface, or dilate the cervix to increase the likelihood of a vaginal delivery". The two major techniques for cervical ripening are mechanical interventions (e.g. insertion of balloon catheters), and application of pharmacological agents (e.g. prostaglandins). Prostaglandins are one of the preferred methods for cervical ripening, including the agents dinoprostone and misoprostol
. By the mid of-1980s prostaglandins had become established as the most effective pharmacological agents for inducing labour when the cervix is unripped. The vaginal route was found to be the most acceptable, providing good efficacy and acceptability for the parturient and it is the preferred choice now.
During the past 15 years the introduction of misoprostol, the prostaglandinsE1(PGE1) which, unlike prostglandinsE2 (PGE2), is stable at room temperature and it is effective if it was taken orally, has been the major focus of attention for labour induction. It is also considerably cheaper than the alternative prostaglandin.
With the ever-increasing concentrations of estrogen in the maternal circulation leading to term pregnancy, the belief that this could be a trigger for the onset of spontaneous labour led the studies to explore estrogens for the induction of labour.
Estradiol gel gives extra--amniotic, endocervical or vaginally or estradiol intramuscularly and estradiol gel extra-amniotic have been shown to produce some improved cervical favorability with minimal myometrial stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginal misoprostol | Active comparator | Drug: Vaginal Tabletonly vaginal misoprostol 25 μg tablets will be applied for induction of laour |
| combined vaginal misoprostol and estradiol | Active comparator | Drug: Vaginal Tabletvaginal misoprostol 25 μg (Vagiprost) tablets with vaginal estradiol 150 ml cream will be applied for induction of laour |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Gestational age36:41 weeks.
- Singleton pregnancy.
- Absence of labour pain.
- Living fetus with cephalic presentation.
- Fetal weight < 4 k.gs.
Key exclusion criteria (9 listed)
- - Multiple gestations. one of the contraindications of induction of labor as it may cause rupture of the uterus.
- Liquor abnormalities.one of contraindications of induction of labor as it may cause fetal distress.
- Abnormal umbilical artery Doppler indices or non-stress test as these indicate fetal distress.
- Fetal weight > 4 kgs.as macrosomia is an indication of caesarean section for fear of shoulder dystocia .
- Previous uterine surgery.contraindication of labor induction for fear of rupture uterus.
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 |
|---|---|---|
| Vaginal TabletAlso: vaginal misoprostol and vaginal estradiolMisoprostol alone will be repeated every 4 h in both groups for a maximum of 5 doses, reaching Bishop score >8, rupture of membranes or occurrence of labor pain. Cervical evaluation will be done using Bishop's score. A score < 5 will be taken as unfavorable Cervix will be termed as ripped when Bishop's score equal 8 or more. The endpoint of the study will be initiation of active phase of 1st stage of labor which commence from 6cm to full cervical dilatation | Drug | combined vaginal misoprostol and estradiol, vaginal misoprostol |
Primary outcome
Induction of labour with closed cervix
Time frame: from 0 hours to 14 hours after induction of labour
assessment of uterine contractions and cervical opening of the pregnant females who are currently not in labour, to help them to reach normal vaginal delivery process.
1 secondary outcome
The Whole Delivery time after induction of labour.
Time frame: from 0 hours to the end of the delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaginal Tablet in people with Cervix; Pregnancy, run by Ain Shams 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 8 inclusion and 9 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 1 Apr 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Amira M Ahmed, MSC (+201090904528, dr_amiramaher@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction of labour with closed cervix (time frame: from 0 hours to 14 hours after induction of labour). 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 1 Apr 2022.