Hydatidiform Mole
Conditions
Keywords
Hydatidiform mole, Molar pregnancy, H Mole, GTN, GTD
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 .
Interventions
PROCEDURESuction 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.
Sponsors
Nilratan Sircar Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patents diagnosed as GTN following treatment in each group | Six months following evacuation |
Secondary
| Measure | Time frame |
|---|---|
| Maternal complications, | Six months |
| Time interval of normalization of HCG | Six months following evacuation |
| Duration of hospital stay | Two weeks following admission |
Countries
India
Contacts
Primary ContactSnehamay Chaudhuri, MD, DNB
Outcome results
None listed