A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
Primary Purpose
Hydatidiform Mole
Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Suction and evacuation
Suction and evacuation
Sponsored by
About this trial
This is an interventional treatment trial for Hydatidiform Mole focused on measuring Hydatidiform mole, Molar pregnancy, H Mole, GTN, GTD
Eligibility Criteria
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
Sites / Locations
- Dr Snehamay ChaudhuriRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single evacuation of mole,
Double evacuation of mole
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patents diagnosed as GTN following treatment in each group
Secondary Outcome Measures
Maternal complications,
Time interval of normalization of HCG
Duration of hospital stay
Full Information
NCT ID
NCT01630954
First Posted
June 24, 2012
Last Updated
March 22, 2016
Sponsor
Nilratan Sircar Medical College
1. Study Identification
Unique Protocol Identification Number
NCT01630954
Brief Title
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
Official Title
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nilratan Sircar Medical College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydatidiform Mole
Keywords
Hydatidiform mole, Molar pregnancy, H Mole, GTN, GTD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single evacuation of mole,
Arm Type
Active Comparator
Arm Title
Double evacuation of mole
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Suction and evacuation
Other Intervention Name(s)
Suction curettage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Suction and evacuation
Other Intervention Name(s)
Suction curettage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patents diagnosed as GTN following treatment in each group
Time Frame
Six months following evacuation
Secondary Outcome Measure Information:
Title
Maternal complications,
Time Frame
Six months
Title
Time interval of normalization of HCG
Time Frame
Six months following evacuation
Title
Duration of hospital stay
Time Frame
Two weeks following admission
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Snehamay Chaudhuri, MD, DNB
Phone
091-33-23537900
Email
snehamay_chaudhuri_dr@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Snehamay Chaudhuri, MD, DNB
Organizational Affiliation
Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Snehamay Chaudhuri
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700010
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Snehamay Chaudhuri, MD, DNB
Phone
91-33-23537900
Email
snehamay_chaudhuri_dr@yahoo.com
First Name & Middle Initial & Last Name & Degree
Snehamay Chaudhuri, MD, DNB
12. IPD Sharing Statement
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A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
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