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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hydatidiform Mole | Procedure: Suction and evacuation | Phase 4 |
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 |

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 |
- Proportion of patents diagnosed as GTN following treatment in each group [ Time Frame: Six months following evacuation ]
- Maternal complications, [ Time Frame: Six months ]
- Time interval of normalization of HCG [ Time Frame: Six months following evacuation ]
- Duration of hospital stay [ Time Frame: Two weeks following admission ]

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Ages Eligible for Study: | 15 Years to 45 Years (Child, Adult) |
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

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
Contact: Snehamay Chaudhuri, MD, DNB | 091-33-23537900 | snehamay_chaudhuri_dr@yahoo.com |
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 |
Principal Investigator: | Snehamay Chaudhuri, MD, DNB | Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India |
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 |
Hydatidiform mole Molar pregnancy H Mole GTN GTD |
Hydatidiform Mole Gestational Trophoblastic Disease Trophoblastic Neoplasms Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Pregnancy Complications, Neoplastic Pregnancy Complications |