A Phase 4 interventional study of Suction and evacuation and Suction and evacuation in Hydatidiform Mole, sponsored by Nilratan Sircar Medical College. Status unknown at 1 site in India. Open to female participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by Nilratan Sircar Medical College · Phase 4, Interventional, and Treatment
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 .
Nilratan Sircar Medical College is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Procedure: Suction and evacuation
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.
Also known as: Suction curettage
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.
Also known as: 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
The record gives a start of Jun 2012, a primary completion of Dec 2018 and a completion of Jun 2019. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Hydatidiform Mole
Nilratan Sircar Medical College