Medical Abortion With Single Daily Dose of Misoprostol

Miscarriage Clinical Trial

Official title:

Medical Abortion With Multiple vs Single Daily Dose of Misoprostol in First Trimester Miscarriage: A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487354
• Other study ID #: AS1753
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Maternal age more than 18 years old (age of legal consent).

• Gestational age less than 13 weeks.

• Hemoglobin >10 g/dL.

• BMI between 25 kg/m2 and 35 kg/m2.

• Missed abortion.

• Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria:

• Maternal age less than 18 years old.

• Gestational age more than 12 weeks.

• Hemoglobin <10 g/dL.

• Anencephaly.

• Fibroid uterus.

• BMI less than 25kg/m2 and more than 35kg/m2.

• Coagulopathy.

• History or evidence of adrenal pathology.

• Previous attempts for induction of abortion in the current pregnancy.

• Allergy to misoprostol or letrozole.

• Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

Intervention

Drug:
• Misoprostol
Misoprostol

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete miscarriage	Assessed by trans-vaginal ultrasound where endometrial thickness less than 15 mm is considered complete miscarriage	one week