Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream
NCT ID: NCT05306405
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2022-02-20
2022-08-30
Brief Summary
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Detailed Description
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. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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vaginal misoprostol
only vaginal misoprostol 25 μg tablets will be applied for induction of laour
Vaginal Tablet
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
combined vaginal misoprostol and estradiol
vaginal misoprostol 25 μg (Vagiprost) tablets with vaginal estradiol 150 ml cream will be applied for induction of laour
Vaginal Tablet
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
Interventions
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Vaginal Tablet
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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
20 Years
39 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Amira Maher
Resident of Obstetrics and Gynecology at Al-Delengat General Hospital
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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