Medical Abortion With Single Daily Dose of Misoprostol

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Miscarriage

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03487354

AS1753

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Single daily dose

Active Comparator group

Treatment:

Drug: Misoprostol

Multiple daily doses

Active Comparator group

Treatment:

Drug: Misoprostol