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

This study is currently recruiting participants.
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

June 24, 2012
June 26, 2012
June 2012
December 2014   (final data collection date for primary outcome measure)
Proportion of patents diagnosed as GTN following treatment in each group [ Time Frame: Six months following evacuation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01630954 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
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 .

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hydatidiform 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
  • 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
  • Active Comparator: Single evacuation of mole,
    Intervention: Procedure: Suction and evacuation
  • Active Comparator: Double evacuation of mole
    Intervention: Procedure: Suction and evacuation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
15 Years to 45 Years
No
Contact: Snehamay Chaudhuri, MD, DNB 091-33-23537900 snehamay_chaudhuri_dr@yahoo.com
India
 
NCT01630954
4-Chaudhuri
Yes
Dr Snehamay Chaudhuri, Nilratan Sircar Medical College
Nilratan Sircar Medical College
Not Provided
Principal Investigator: Snehamay Chaudhuri, MD, DNB Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
Nilratan Sircar Medical College
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP