Clinical trial NCT05306405: Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream
Official title: Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cervix; Pregnancy
Keywords: cervical dilatation, Uneffaced cervix, closed os
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* - 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.
* 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

Primary outcomes:
measure: Induction of labour with closed cervix
timeFrame: from 0 hours to 14 hours after induction of labour
Secondary outcomes:
measure: The Whole Delivery time after induction of labour.
timeFrame: from 0 hours to the end of the delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: