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

Study Overview
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Brief Summary
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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 .

Official Title
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A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform

Conditions
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Hydatidiform Mole

Intervention / Treatment
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* Procedure: Suction and evacuation
* Procedure: Suction and evacuation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single evacuation of mole,<br> | Procedure: Suction and evacuation<br>* 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.<br>* Other names: Suction curettage;|
| Active Comparator: Double evacuation of mole<br> | Procedure: Suction and evacuation<br>* 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.<br>* Other names: Suction curettage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patents diagnosed as GTN following treatment in each group |  | Six months following evacuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal complications, |  | Six months | 
| Time interval of normalization of HCG |  | Six months following evacuation | 
| Duration of hospital stay |  | Two weeks following admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydatidiform mole, Molar pregnancy, H Mole, GTN, GTD