NCT01630954

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

6.5 years

First QC Date

June 24, 2012

Last Update Submit

March 22, 2016

Conditions

Hydatidiform Mole

Keywords

Hydatidiform moleMolar pregnancyH MoleGTNGTD

Outcome Measures

Primary Outcomes (1)

  • Proportion of patents diagnosed as GTN following treatment in each group

    Six months following evacuation

Secondary Outcomes (3)

  • Maternal complications,

    Six months

  • Time interval of normalization of HCG

    Six months following evacuation

  • Duration of hospital stay

    Two weeks following admission

Study Arms (2)

Single evacuation of mole,

ACTIVE COMPARATOR
Procedure: Suction and evacuation

Double evacuation of mole

ACTIVE COMPARATOR
Procedure: Suction and evacuation

Interventions

Suction and evacuationPROCEDURE

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.

Also known as: Suction curettage
Single evacuation of mole,

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ultrasound confirmed complete mole

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Snehamay Chaudhuri

Kolkata, West Bengal, 700010, India

RECRUITING

MeSH Terms

Conditions

Hydatidiform Mole

Interventions

SuctionVacuum Curettage

Condition Hierarchy (Ancestors)

Gestational Trophoblastic DiseaseTrophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsPregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, OperativeDilatation and CurettageCurettageGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Snehamay Chaudhuri, MD, DNB

    Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Snehamay Chaudhuri, MD, DNB

CONTACT

091-33-23537900snehamay_chaudhuri_dr@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor,Obstetrics and Gynecology, NRS Medical College

Study Record Dates

First Submitted

June 24, 2012

First Posted

June 28, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

IN(1)