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

March 22, 2016 updated by: Dr Snehamay Chaudhuri, Nilratan Sircar Medical College

A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform

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 .

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • West Bengal
      • Kolkata, West Bengal, India, 700010
        • Recruiting
        • Dr Snehamay Chaudhuri
        • Contact:
        • Principal Investigator:
          • Snehamay Chaudhuri, MD, DNB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Single evacuation of mole,
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.
Other Names:
  • Suction curettage
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.
Other Names:
  • Suction curettage
ACTIVE_COMPARATOR: Double evacuation of mole
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.
Other Names:
  • Suction curettage
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.
Other Names:
  • Suction curettage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patents diagnosed as GTN following treatment in each group
Time Frame: Six months following evacuation
Six months following evacuation

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal complications,
Time Frame: Six months
Six months
Time interval of normalization of HCG
Time Frame: Six months following evacuation
Six months following evacuation
Duration of hospital stay
Time Frame: Two weeks following admission
Two weeks following admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

June 24, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (ESTIMATE)

June 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hydatidiform Mole

Clinical Trials on Suction and evacuation

Subscribe