- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630954
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Snehamay Chaudhuri, MD, DNB
- Phone Number: 091-33-23537900
- Email: snehamay_chaudhuri_dr@yahoo.com
Study Locations
-
-
West Bengal
-
Kolkata, West Bengal, India, 700010
- Recruiting
- Dr Snehamay Chaudhuri
-
Contact:
- Snehamay Chaudhuri, MD, DNB
- Phone Number: 91-33-23537900
- Email: snehamay_chaudhuri_dr@yahoo.com
-
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:
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:
|
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:
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:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-Chaudhuri
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.
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