Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

Abortion, Missed Clinical Trial

Official title:

Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148314
• Other study ID #: VMIS
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Abortion, Missed

Intervention

Drug:
• vaginal misoprostol
(800µgm.x 2 doses 3 hours).
• buccal/sublingual misoprostol
200 µgm.x4 hrs.x 6 doses

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with complete abortion (success rate).		1 week
Secondary	Number of misoprostol doses		1 week
Secondary	induction-abortion time		1 week