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

Sponsor
Nilratan Sircar Medical College (Other)
Overall Status
Unknown status
CT.gov ID
NCT01630954
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
84
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: Suction and evacuation
  • Procedure: Suction and evacuation
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform
Study Start Date :
Jun 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Single evacuation of mole,

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.
Other Names:
  • Suction curettage

    		•
    Active Comparator: Double evacuation of mole

    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.
    Other Names:
  • Suction curettage

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patents diagnosed as GTN following treatment in each group [Six months following evacuation]

    Secondary Outcome Measures

    1. Maternal complications, [Six months]

    2. Time interval of normalization of HCG [Six months following evacuation]

    3. Duration of hospital stay [Two weeks following admission]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr Snehamay Chaudhuri Kolkata West Bengal India 700010

    Sponsors and Collaborators

    • Nilratan Sircar Medical College

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Snehamay Chaudhuri, Associate Professor,Obstetrics and Gynecology, NRS Medical College, Nilratan Sircar Medical College
    ClinicalTrials.gov Identifier:
    NCT01630954
    Other Study ID Numbers:
    • 4-Chaudhuri
    First Posted:
    Jun 28, 2012
    Last Update Posted:
    Mar 23, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Dr Snehamay Chaudhuri, Associate Professor,Obstetrics and Gynecology, NRS Medical College, Nilratan Sircar Medical College
    Hydatidiform mole
    Molar pregnancy
    H Mole
    GTN
    GTD
    Additional relevant MeSH terms:
    Hydatidiform Mole

    Study Results

    No Results Posted as of Mar 23, 2016