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

Nilratan Sircar Medical College

Status and phase: Unknown; Phase 4

Conditions: Hydatidiform Mole

Treatments: Procedure: Suction and evacuation

Study type: Interventional

Funder types: Other

Identifiers

NCT01630954

4-Chaudhuri

Details and patient eligibility

About

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 .

Enrollment: 120 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Single evacuation of mole,

Active Comparator group

Treatment:

Procedure: Suction and evacuation

Procedure: Suction and evacuation

Double evacuation of mole

Active Comparator group

Treatment:

Procedure: Suction and evacuation

Procedure: Suction and evacuation