Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02265562

Enrollment

220

Registered

2014-10-16

Start date

2014-10-31

Completion date

2015-06-30

Last updated

2014-10-16

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

Conditions

Blood Loss

Keywords

Hysterectomy, Misoprostol, Blood loss

Brief summary

Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.

Detailed description

In this study we tried to assess the efficacy of misoprostol in minimize blood loss during hysterectomy when used as single preoperative dose via rectal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect

Interventions

DRUGMisoprostol

60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally

DRUGPlacebo

60 minutes before the surgery 2 tablet of placebo inserted rectally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

A- Age: adult female \>18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol.

Exclusion criteria

A -Women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease. B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues and mifepristone and who are allergic to prostaglandins. F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish to participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
Blood loss	8 months	amount of intra-operative blood loss

Secondary

Measure	Time frame	Description
postoperative hemoglobin level	8 months	level of serum hemoglobin postoperatively

Countries

Egypt

Contacts

Primary ContactWaleed EL-khayat, M.D.

waleed_elkhyat@yahoo.com01005135542

Outcome results

None listed

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