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Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy

M

Mansoura University

Status and phase

Completed
Phase 4

Conditions

Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy

Treatments

Drug: 2 doses 400 microgram misoprostol
Drug: single dose misoprostol

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.

Enrollment

69 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)

Exclusion criteria

  • hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index >30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

69 participants in 2 patient groups

double dose misoprostol
Active Comparator group
Description:
2 doses, 3 and 1 hours, prior surgery (group B, 35 cases).
Treatment:
Drug: 2 doses 400 microgram misoprostol
single dose Misoprostol
Active Comparator group
Description:
intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases)
Treatment:
Drug: single dose misoprostol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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