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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Nilratan Sircar Medical College
Sponsor:
Information provided by (Responsible Party):
Dr Snehamay Chaudhuri, Nilratan Sircar Medical College
ClinicalTrials.gov Identifier:
NCT01630954
First received: June 24, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Hydatidiform Mole
Procedure: Suction and evacuation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform

Resource links provided by NLM:


Further study details as provided by Nilratan Sircar Medical College:

Primary Outcome Measures:
  • Proportion of patents diagnosed as GTN following treatment in each group [ Time Frame: Six months following evacuation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal complications, [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • Time interval of normalization of HCG [ Time Frame: Six months following evacuation ] [ Designated as safety issue: Yes ]
  • Duration of hospital stay [ Time Frame: Two weeks following admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Suction curettage

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630954

Contacts
Contact: Snehamay Chaudhuri, MD, DNB 091-33-23537900 snehamay_chaudhuri_dr@yahoo.com

Locations
India
Dr Snehamay Chaudhuri Recruiting
Kolkata, West Bengal, India, 700010
Contact: Snehamay Chaudhuri, MD, DNB    91-33-23537900    snehamay_chaudhuri_dr@yahoo.com   
Principal Investigator: Snehamay Chaudhuri, MD, DNB         
Sponsors and Collaborators
Nilratan Sircar Medical College
Investigators
Principal Investigator: Snehamay Chaudhuri, MD, DNB Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
  More Information

No publications provided

Responsible Party: Dr Snehamay Chaudhuri, Associate Professor,Obstetrics and Gynecology, NRS Medical College, Nilratan Sircar Medical College
ClinicalTrials.gov Identifier: NCT01630954     History of Changes
Other Study ID Numbers: 4-Chaudhuri
Study First Received: June 24, 2012
Last Updated: June 26, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Nilratan Sircar Medical College:
Hydatidiform mole
Molar pregnancy
H Mole
GTN
GTD

Additional relevant MeSH terms:
Gestational Trophoblastic Disease
Hydatidiform Mole
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Pregnancy Complications
Pregnancy Complications, Neoplastic
Trophoblastic Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014