A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole

Phase 4

• Conditions: Hydatidiform Mole
• Interventions: Procedure: Suction and evacuation

• Registration Number: NCT01630954
• Lead Sponsor: Nilratan Sircar Medical College

Brief Summary

Hydatidiform mole is a common complication of pregnancy with an incidence of 1in 400 pregnancies in India. Although this is a benign condition , it is having the malignant potential too. A repeat curettage after evacuation of hydatidiform mole was generally advocated till 1990s. A thorough curettage at the time of initial evacuation was not performed because of larger size of uterus and risk of perforation. Subsequently a number of studies assessed the usefulness of repeat curettage and found it was unnecessary and not cost effective . However all these studies are retrospective in design and conducted in developed countries where hydatidiform mole is diagnosed earlier because of wider use of ultrasonography. Thus there is a need to perform a well designed prospective study to compare the effectiveness of single evacuation with double evacuation in treatment of hydatidiform mole for prevention of Gestational Trophoblastic Neoplasia.This study compares the effectiveness of single evacuation versus double evacuation for treatment of hydatidiform mole for prevention of gestational trophoblastic neoplasia .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-24
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Ultrasound confirmed complete mole

Exclusion Criteria

• Partial mole
• History of treatment for molar pregnancy like prior evacuation or chemotherapy
• Women requiring hysterectomy for treatment of H Mole

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double evacuation of mole	Suction and evacuation	-
Single evacuation of mole,	Suction and evacuation	-

Primary Outcome Measures

Name	Time	Method
Proportion of patents diagnosed as GTN following treatment in each group	Six months following evacuation

Secondary Outcome Measures

Name	Time	Method
Maternal complications,	Six months
Time interval of normalization of HCG	Six months following evacuation
Duration of hospital stay	Two weeks following admission

Trial Locations

Locations (1)

Dr Snehamay Chaudhuri; 🇮🇳 Kolkata, West Bengal, India