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

A

Aswan University Hospital

Status and phase

Unknown
Phase 4

Conditions

Abortion, Missed

Treatments

Drug: Isonicotinic Acid
Drug: Placebo
Drug: Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT04499976
aswu/353/3/19

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 2 patient groups, including a placebo group

INH
Experimental group
Description:
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.
Treatment:
Drug: Misoprostol
Drug: Isonicotinic Acid
Placebo Comparator
Placebo Comparator group
Description:
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
Treatment:
Drug: Misoprostol
Drug: Placebo

Trial contacts and locations

0

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Central trial contact

hany f Sallam, md; nahla w Shady, md

Data sourced from clinicaltrials.gov

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