Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage

Phase 4

• Conditions: Abortion, Missed
• Interventions: Drug: Placebo; Drug: Isonicotinic Acid; Drug: Misoprostol

• Registration Number: NCT04499976
• Lead Sponsor: Aswan University Hospital

Brief Summary

This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

Detailed Description

In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . Misoprostol is a synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05
• Study Start: 2020-09-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Gestational age less than 70 days gestation (<10 wks).
• Hemoglobin >10 g/dL.
• BMI between 18.5 kg/m2 and 30 kg/m2.
• Missed abortion
• previous one or more cesarean deliveries

Exclusion Criteria

• Molar pregnancy
• Fibroid uterus.
• Uterine anomalies.
• Coagulopathy
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).
• Previous attempts for induction of abortion in the current pregnancy.
• Allergy to misoprostol or INH.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo	three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
INH	Misoprostol	3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
INH	Isonicotinic Acid	3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
Placebo Comparator	Misoprostol	three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses

Primary Outcome Measures

Name	Time	Method
number of patient with complete abortion	9 hours	number of patient with complete abortion
induction to abortion time	9 hours	induction to abortion time

Secondary Outcome Measures

Name	Time	Method
number of patient need for surgical evacuation of the products of conception	12 hours	number of patient need for surgical evacuation of the products of conception

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt