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

Single Versus Double Dose Intra-vaginal Prostaglandin E2 Misoprostol Prior Abdominal Myomectomy: A Randomized Controlled Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02154932

Enrollment

Registered

2014-06-03

Start date

2011-01-31

Completion date

2013-01-31

Last updated

2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostaglandin E2 Misoprostol Prior Abdominal Myomectomy

Keywords

Myomectomy, Misoprostol

Brief summary

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.

Interventions

DRUG2 doses 400 microgram misoprostol

2 doses 400 microgram misoprostol, 3 and 1 hours

DRUGsingle dose misoprostol

1 dose, 1 hours, prior surgery

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
the operative time	from skin to skin in minutes	The time from start till end of surgery
intra and post-operative blood loss	during and 6 hours after surgery	collected soaked towels and sucked blood

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026