Role of rectal Misoprostol along with intramyometrial Vasopressin in reducing blood loss during Laparoscopic removal of fibroids.

To compare the efficacy of Intramyometrial Vasopressin plus Rectal Misoprostol with Intramyometrial Vasopressin alone to decrease blood loss during Laparoscopic Myomectomy: A Randomised Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009677

Enrollment

Registered

2017-09-07

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- Patients planned for laparoscopic myomectomy and meeting the inclusion and exclusion criteria

Interventions

Intervention1: Preoperative per rectal misoprostol 600 mcg: Plus Intraoperative vasopressin (20 units) Control Intervention1: Only intra operative vasopressin: 20 units Control Intervention2: Only int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women between 16-45 years of age 2. Myomatous uterus corresponding to 28 weeks size or less 3. Largest fibroid less than 15 cm 4. Haemoglobin level equal to or greater than 9 g/dL 5. No contraindication to use of vasopressin or misoprostol (renal/heart disease)

Exclusion criteria

Exclusion criteria: 1. Previous myomectomy 2. Significant medical condition such as heart, renal or pulmonary disease 3. Hb 4. Pregnancy 5. History of any bleeding disorder 6. Concurrent anticoagulation therapy 7. Grade 0 submucosal fibroid 8. Patient not fit for laparoscopic surgery

Design outcomes

Primary

Measure	Time frame
Intraoperative blood loss in vasopressin plus misoprostol group versus only vasopressin group.Timepoint: Measured immediately after the end of surgery	—

Secondary

Measure	Time frame
Intraoperative: 1. Ease of myoma separation/enucleation 2. Need of any additional haemostatic measure 3. Need for blood transfusion 4. No. and type of sutures used 5. Rate of conversion to laparotomy 6. Need for hysterectomy 7. Duration of surgery 8. Any other complication Postoperative 1. Hb drop and change in other blood counts 2. Morbidity like pyrexia (temp 100 Â°F), diarrhoea 3. Need for blood transfusion 4. Length of hospital stay 5. Evaluation on f/up visits at 1 and 6 wksTimepoint: till 48 hrs postoperative	—

Measure

Time frame

Intraoperative: 1. Ease of myoma separation/enucleation 2. Need of any additional haemostatic measure 3. Need for blood transfusion 4. No. and type of sutures used 5. Rate of conversion to laparotomy 6. Need for hysterectomy 7. Duration of surgery 8. Any other complication Postoperative 1. Hb drop and change in other blood counts 2. Morbidity like pyrexia (temp 100 Â°F), diarrhoea 3. Need for blood transfusion 4. Length of hospital stay 5. Evaluation on f/up visits at 1 and 6 wksTimepoint: till 48 hrs postoperative

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Countries

India

Contacts

Public ContactDr Sonal Srivastava

All India Institute of Medical Sciences

drsonal2808@gmail.com9962722166

Outcome results

None listed

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