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

NCT01630954 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-03-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nilratan Sircar Medical College

    lead OTHER_GOV

Principal Investigators

  • Snehamay Chaudhuri, MD, DNB · Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2018-12-31
Completion
2019-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01630954 on ClinicalTrials.gov