Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

Assiut University

Status and phase: Completed; Phase 2

Conditions: Abortion, Missed

Treatments: Drug: vaginal misoprostol; Drug: buccal/sublingual misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03148314

VMIS

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

hospital- based vaginal misoprostol

Active Comparator group

Description:

hospital- based vaginal misoprostol

Treatment:

Drug: vaginal misoprostol

extended low dose oral misoprostol

Active Comparator group

Description:

extended low dose oral misoprostol

Treatment:

Drug: buccal/sublingual misoprostol