Comparison of reduction of blood loss at myomectomy using Misoprostol to that of Haemostatic Torniquet

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201802003039106
• Date of registration: 02/02/2018
• Prospective Registration: No
• Primary sponsor: University of Ilorin Teaching Hospital
• Public title: Comparison of reduction of blood loss at myomectomy using Misoprostol to that of Haemostatic Torniquet
• Scientific title: Comparing Perioperative Vaginal Misoprostol With Intraoperative Pericervical Haemostatic Tourniquet In Reducing Blood Loss During Abdominal Myomectomy
• Date of first enrolment: 02/06/2016
• Target sample size: 80
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3039
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised, Simple randomisation using a radomisation table created by a computer software program ,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Nigeria

Contacts

• Name: ABIODUN ADENIRAN
• Affiliation: CONSULTANT

• Name: MUHIBAT AFOLABI
• Affiliation: SENIOR REGISTRAR

Key inclusion & exclusion criteria

Inclusion criteria: Diagnosis of uterine fibroid with a treatment plan for abdominal myomectomy
Exclusion criteria: Exclusion criteria:
1.Known allergy to prostaglandins including misoprostol.
2.Chronic medical disorders including hypertension, diabetes mellitus, cardiac or pulmonary diseases.
3.Previous uterine surgery (myomectomy or caesarean section).
4.Known bleeding or clotting disorders.
5.Haematocrit at 24hours before surgery less than 30%.
6.Patient refusal to participate in the study.


Age minimum: 20 Year(s)
Age maximum: 48 Year(s)
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Fibroid

Fertility-female
Uterine Fibroid

Fertility-female

Intervention(s)

Perioperative Vaginal Misoprostol

Pericervical Haemostatic Torniquet

Primary Outcome(s)

Intra-operative blood loss andNeed for intra-operative blood transfusion.

Secondary Outcome(s)

1. Occurrences of side effects of Misoprostol including nausea, vomiting, diarrhoea, shivering and elevated temperature (temperature ¿ 380C). 2. Need for hysterectomy. 3. Post-operative haematocrit. 4. Need for post-operative blood transfusion.

Secondary ID(s)

ERCPAN/2015/09/1455

Source(s) of Monetary Support

University of Ilorin Teaching Hospital

Ethics review

Status: Approved
Approval date: 10/09/2015
Contact:

Ethical Review Committee of the University of Ilorin Teaching Hospital