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

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ClinicalTrials.gov Identifier: NCT01630954
Recruitment Status : Unknown
Verified March 2016 by Dr Snehamay Chaudhuri, Nilratan Sircar Medical College.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Snehamay Chaudhuri, Nilratan Sircar Medical College

Study Description
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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
Hydatidiform Mole Procedure: Suction and evacuation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Moles

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patents diagnosed as GTN following treatment in each group [ Time Frame: Six months following evacuation ]

Secondary Outcome Measures :
  1. Maternal complications, [ Time Frame: Six months ]
  2. Time interval of normalization of HCG [ Time Frame: Six months following evacuation ]
  3. Duration of hospital stay [ Time Frame: Two weeks following admission ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630954


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

Locations
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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
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Principal Investigator: Snehamay Chaudhuri, MD, DNB Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
More Information
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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: June 28, 2012    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Keywords provided by Dr Snehamay Chaudhuri, Nilratan Sircar Medical College:
Hydatidiform mole
Molar pregnancy
H Mole
GTN
GTD
Additional relevant MeSH terms:
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Hydatidiform Mole
Gestational Trophoblastic Disease
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Pregnancy Complications, Neoplastic
Pregnancy Complications