Hydatidiform MolePhase 4NCT01630954
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
A Phase 4 study testing Suction and evacuation in people with Hydatidiform Mole, run by Nilratan Sircar Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Hydatidiform Mole
- What is being tested?
- Suction and evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2012to Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ultrasound confirmed complete mole
Who cannot join
- Partial mole
- History of treatment for molar pregnancy like prior evacuation or chemotherapy
- Women requiring hysterectomy for treatment of H Mole
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr Snehamay Chaudhuri
Kolkata, West Bengal, 700010
Snehamay Chaudhuri, MD, DNB, 91-33-23537900, snehamay_chaudhuri_dr@yahoo.com
Snehamay Chaudhuri, MD, DNB
About this study
Official title: A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform
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 .
- Conditions
- Hydatidiform Mole
- Being tested
- Suction and evacuation
- Keywords
- Hydatidiform mole, Molar pregnancy, H Mole, GTN, GTD
- Medical subject headings
- Hydatidiform Mole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction and evacuationProcedure or surgery
Also called Suction curettage
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.
Suction and evacuationProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Single evacuation of mole, | Active comparator | Not described Receives: Procedure: Suction and evacuation |
| Double evacuation of mole | Active comparator | Not described Receives: Procedure: Suction and evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patents diagnosed as GTN following treatment in each group
Measured: Six months following evacuation
Secondary outcomes (3)
Maternal complications,
Measured: Six months
Time interval of normalization of HCG
Measured: Six months following evacuation
Duration of hospital stay
Measured: Two weeks following admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydatidiform MoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nilratan Sircar Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Snehamay Chaudhuri, Nilratan Sircar Medical College
- Investigators
- Snehamay Chaudhuri, MD, DNB, Principal investigator, Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630954
- Sponsor's protocol ID
- 4-Chaudhuri
- Status last verified
- Mar 2016
- First submitted
- 24 Jun 2012
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform
- ClinicalTrials.gov ID
- NCT01630954
- Acronym / sponsor ID
- 4-Chaudhuri
- Conditions
- Hydatidiform Mole
- Keywords
- Hydatidiform mole, Molar pregnancy, H Mole, GTN, GTD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nilratan Sircar Medical CollegeOther government
- Study start
- Jun 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single evacuation of mole, | Active comparator | Procedure: Suction and evacuation |
| Double evacuation of mole | Active comparator | Procedure: Suction and evacuation |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Ultrasound confirmed complete mole
Key exclusion criteria (3 listed)
- Partial mole
- History of treatment for molar pregnancy like prior evacuation or chemotherapy
- Women requiring hysterectomy for treatment of H Mole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction and evacuationAlso: Suction curettageIn 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. | Procedure or surgery | Single evacuation of mole, |
| Suction and evacuationAlso: Suction curettageIn 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. | Procedure or surgery | Double evacuation of mole |
Primary outcome
Proportion of patents diagnosed as GTN following treatment in each group
Time frame: Six months following evacuation
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snehamay Chaudhuri, MD, DNB principal investigator
Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suction and evacuation in people with Hydatidiform Mole, run by Nilratan Sircar Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Snehamay Chaudhuri, MD, DNB (091-33-23537900, snehamay_chaudhuri_dr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patents diagnosed as GTN following treatment in each group (time frame: Six months following evacuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.