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effect of drug misoprostol on operative blood loss in bulky uteruses during removal of uterus operation

A RANDOMISED STUDY OF SINGLE PRE-OPERATIVE VAGINAL MISOPROSTOL IN REDUCING OPERATIVE BLOOD LOSS DURING ABDOMINAL HYSTERECTOMY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009494
Enrollment
70
Registered
2017-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- planned for hysterectomy due to menorrhagia

Interventions

Intervention1: misoprostol tablet: misoprostol vaginal tablet to be given half hour before hysterectomy Control Intervention1: placebo tablets: placebo tablets to be given vaginally half hour before h

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Symptomatic women undergoing total abdominal hysterectomy for various benign gynaecological diseases like 1) Fibroid uterus 2) Adebomyotic uterus 3) AUB not responding to medical management size >10 cms

Exclusion criteria

Exclusion criteria: 1. Hysterectomy to be performed for malignant diseases 2. Any contraindication to misoprostol (mitral stenosis, glaucoma, sickle cell anemia, diastolic blood pressure >100 mm Hg , severe asthma or known allergy to prostaglandins.) 3. Pelvic/ovarian endometriosis , associated PID , where dense pelvic adhesions are anticipated 4. History of active medical disease 5. History of myomectomy 6. Women who had pre-operative mifepristone or gonadotrophin releasing hormone analogues treatment 7. Women with mental impairment or incompetent in giving consent.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure : Intra-operative blood loss (in ml)Timepoint: Primary outcome measure : Intra-operative blood loss (in ml) Secondary outcome measures : 1) Requirement for post operative blood transfusion 2) Requirement for injectable iron 3) Change in hemoglobin level after operation 4) Incidence of side effects (drug , wound, pelvic collection)

Secondary

MeasureTime frame
Secondary outcome measures : 1) Requirement for post operative blood transfusion 2) Requirement for injectable iron 3) Change in hemoglobin level after operation 4) Incidence of side effects (drug , wound, pelvic collection) Timepoint: one week after operation

Countries

India

Contacts

Public ContactMonika Anant

All India Institute of Medical Sciences Patna

drmonika.anant@gmail.com7764946249

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026