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

Hydatidiform Mole Clinical Trial

Official title:

A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01630954
• Other study ID #: 4-Chaudhuri
• Status: Recruiting
• Phase: Phase 4
• First received: June 24, 2012
• Last updated: March 22, 2016
• Start date: June 2012
• Est. completion date: June 2019

Study information

• Verified date: March 2016
• Source: Nilratan Sircar Medical College
• Contact: Snehamay Chaudhuri, MD, DNB
• Phone: 091-33-23537900
• Email: snehamay_chaudhuri_dr[@]yahoo.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hydatidiform Mole

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Dr Snehamay Chaudhuri	Kolkata	West Bengal

Sponsors (1)

Lead Sponsor	Collaborator
Nilratan Sircar Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patents diagnosed as GTN following treatment in each group		Six months following evacuation	Yes
Secondary	Maternal complications,		Six months	Yes
Secondary	Time interval of normalization of HCG		Six months following evacuation	Yes
Secondary	Duration of hospital stay		Two weeks following admission	No