NCT05306405

Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream

Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labour

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervix; Pregnancy

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2022-02-20
• Primary completion: 2022-08-01
• Completion: 2022-08-30
• First posted: 2022-04-01
• Last updated: 2022-04-01

Locations

1 site across 1 country: Egypt