Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Blood Loss

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02265562

10102014

Details and patient eligibility

About

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.

Full 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

Enrollment: 220 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

220 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Description:

60 minutes before the surgery 2 tablets of placebo tablets inserted rectally

Treatment:

Drug: Placebo