Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

NCT03148314 | Completed Phase 2

• 1 other identifier: VMIS
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion

Conditions

Abortion, Missed

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with complete abortion (success rate).

  1 week

Secondary Outcomes (2)

• Number of misoprostol doses

  1 week

• induction-abortion time

  1 week

Study Arms (2)

hospital- based vaginal misoprostol

ACTIVE COMPARATOR

hospital- based vaginal misoprostol

Drug: vaginal misoprostol

extended low dose oral misoprostol

ACTIVE COMPARATOR

extended low dose oral misoprostol

Drug: buccal/sublingual misoprostol

Interventions

vaginal misoprostol DRUG

(800µgm.x 2 doses 3 hours).

Also known as: buccal/sublingual misoprostol

hospital- based vaginal misoprostol

buccal/sublingual misoprostol DRUG

200 µgm.x4 hrs.x 6 doses

Also known as: vaginal misoprostol

extended low dose oral misoprostol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• single dead fetus up-to 12 weeks.
• no low lying placenta
• no scarred uterus
• no or mild bleeding
• no evidence of infection
• accepting to participate in the study.

You may not qualify if:

• Advanced hepatic diseases .
• Suspected molar pregnancy
• Ectopic pregnancy or pregnancy of unknown location
• Haemodynamically unstable with significant anaemia ie Hb\<10
• Uncontrolled severe asthma
• Chronic adrenal failure
• Known or suspected heart disease
• Glaucoma
• Haemoglobinopathies
• Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
• Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
• Patient living in remote areas with difficulty in accessing hospital

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

Related Publications (1)

• Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.

  PMID: 34061352 DERIVED

MeSH Terms

Conditions

Abortion, Missed

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 11, 2017
• Study Start: July 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)