NCT01630954

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

A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nilratan Sircar Medical College · Other Government
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Hydatidiform Mole

Interventions

Type	Name	Description
PROCEDURE	Suction and evacuation	In single evacuation group women will be treated by suction evacuation and curettage is performed at the end of evacuation in one sitting. An ultrasound will be done later to examine completeness of evacuation. If there is significant amount of residual molar tissue or persistence of heavy bleeding a repeat curettage will be done . Women will be followed up with serum beta hcg 1 week after the evacuation and then weekly till the titer is negative. After three consecutive negative titre beat HCG estimation will be done at two weekly interval.
PROCEDURE	Suction and evacuation	In double evacuation group , women will be treated by suction evacuation and a thorough curettage will be avoided. A second evacuation with thorough curettage will be performed after 5 - 7 days of first evacuation.

Timeline

• Start date: 2012-06-01
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2012-06-28
• Last updated: 2016-03-23

Locations

1 site across 1 country: India