A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
Information source: Nilratan Sircar Medical College
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hydatidiform Mole
Intervention: Suction and evacuation (Procedure); Suction and evacuation (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nilratan Sircar Medical College Official(s) and/or principal investigator(s):
Snehamay Chaudhuri, MD, DNB, Principal Investigator, Affiliation: Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
Overall contact:
Snehamay Chaudhuri, MD, DNB, Phone: 091-33-23537900, Email: snehamay_chaudhuri_dr@yahoo.com
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 .
Clinical Details
Official title: A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of patents diagnosed as GTN following treatment in each group
Secondary outcome: Maternal complications,Time interval of normalization of HCG Duration of hospital stay
Eligibility
Minimum age: 15 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Snehamay Chaudhuri, MD, DNB, Phone: 091-33-23537900, Email: snehamay_chaudhuri_dr@yahoo.com
Dr Snehamay Chaudhuri, Kolkata, West Bengal 700010, India; Recruiting
Snehamay Chaudhuri, MD, DNB, Phone: 91-33-23537900, Email: snehamay_chaudhuri_dr@yahoo.com
Snehamay Chaudhuri, MD, DNB, Principal Investigator
Additional Information
Starting date: June 2012
Last updated: July 21, 2015
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