Comparative study of two drugs(Dinoprostone gel and mifepristone)for labour pain stimulation

Phase 2

Not yet recruiting

• Conditions: Prolonged first stage (of labor),

• Registration Number: CTRI/2022/09/045885
• Lead Sponsor: Dr P Srirohini

Brief Summary

Induction of labour is stimulation of uterine contractions before the spontaneous onset of labour with or without ruptured membranes. Labour induction is usually carried out for maternal and fetal conditions.



PGE2, PGE1 and Oxytocin are the most common pharmacological agents used for labour induction.



Prostaglandin E2(PGE2) is effective in achieving cervical ripening and also in activating myometrial contractility.



Mifepristone is a potent antiprogesterone and antiglucocorticoid Compound.It also increases uterine activity and causes cervical effacement and dilation and termination of pregnancy.



Mifepristone has an established role in termination of pregnancy during the early first and the second trimesters.

Recent researches done in India have shown mifepristone is effective as a cervical ripening agent in labour induction with higher rate of vaginal delivery with insignificant maternal and perinatal complications.4,5



Dinoprostone (PGE2) gel is also a effective cervical agent but it needs strict aseptic precautions,skill for intracervical insertion and requires refrigerator for storage whereas Oral Mifepristone is easy to administer,stable at room temperature and patient can remain ambulatory which is more convenient for the patients



Present study is being performed to determine the safety and efficacy of oral mifepristone and compare it with intracervical Dinoprostone gel as a cervical ripening agent in low risk singleton pregnant women who have completed 40weeks of pregnancy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-09-23
• Study Start: 2022-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Willing to participate 2.
• Primigravida 3.
• Singleton pregnancy,Cephalic presentation.
• Gestational age 40+ weeks.
• Maternal age>19years 6.
• No contraindications for prostaglandins or mifepristone.
• No contraindication for vaginal delivery 8.
• Modified Bishop’s Score < 6 9.
• Intact membranes.
• 10.Women with history of 1 or 2 previous abortions.

Exclusion Criteria

• Breech presentation Cephalopelvic disproportion History of 3 or more abortions Estimated fetal weight > 4.5 kg or < 2kg Multigravida,Twin pregnancy Obstetric complications like Diabetes ,Abruptio placenta or Placenta previa.
• Abnormal fetal heart rate patterns.
• Premature rupture of membranes.
• Active genital infection.
• Contraindication for mifepristone Chorioamnionitis Myoma or uterine anomalies IUD’S IVF Conception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bishop score	at 8, 16 and 24 hours after administration of the drug

Secondary Outcome Measures

Name	Time	Method
Induction to delivery interval,mode of delivery,,cesarean for failed induction ,any adverse events,maternal and fetal outcome	24 -48 hours

Trial Locations

Locations (1)

ESIC MC and PGIMSR; 🇮🇳 Chennai, TAMIL NADU, India

ESIC MC and PGIMSR

🇮🇳Chennai, TAMIL NADU, India

Dr P srirohini

Principal investigator

7904041564

rohinisri18@gmail.com