Gestational trophoblastic tumor of pregnancy consist of a group of disorders like complete and partial, invasive mole and placental site tumor and choriocarcinoma. All of them have different tendency for invasion and metastasis. This is a specific tumor of reproductive age and most of patients are under 35 years old. The incidence of molar pregnancy in Asia is 7-10 times more than United States and Europe. Regarding of this reproductive age disorder sometimes hysterectomy is necessary for cure which leads to sterility. However timed diagnosis and treatment leads to 90% percent complete recovery
All patients who had history of D&C and molar pregnancy at pathologic report and the level of B-hCG is plateau or rising and they are referred for chemotherapy , are recruited in this trial. All of them will undergo under hysteroscopic resection of molar residue and then the B-hcg levels, TVS and pathologic reports will be evaluated. If the B-hCG is negative chemotherapy will be cancelled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601222576N11
Registration date:2016-08-26, 1395/06/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-26, 1395/06/05
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-02, 1394/11/13
Expected recruitment end date
2018-02-12, 1396/11/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of hysteroscopy in management of persistent mole
Public title
Role of hysteroscopy in management of persistent mole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with persistent mole(residual of pregnancy in trans vaginal sonography and positive hCG after D&C) are recruited in the study.
Exclusion criterion: patients who prefer chemotherapy instead of hysteroscopy.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Commitee of Tehran University of Medical Sciences
Street address
Fifth floor, Central building of TUMS, Ghods Avenue, Keshavarz Boulvard
City
Tehran
Postal code
Approval date
2016-01-20, 1394/10/30
Ethics committee reference number
IR.TUMS.REC.1395.2799
Health conditions studied
1
Description of health condition studied
Molar Pregnancy
ICD-10 code
O01.9
ICD-10 code description
Hydatidiform mole, unspecified
Primary outcomes
1
Description
B-hCG levels decrease
Timepoint
After one week
Method of measurement
ml/Unit/ml
Secondary outcomes
1
Description
No residuea of pregnancy after hysteroscopy
Timepoint
After one week
Method of measurement
Trans vaginal sonography
Intervention groups
1
Description
Intervention: Hysteroscopic resection of molar tissues in 30 patients
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Women Hospital of Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy Research of Tehran University of Medical Sciences
Full name of responsible person
Mis Hajar Moamaei
Street address
Fifth floor- Central building of TUMS, Ghods Avenue, Keshavarz Boulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate professor of TUMS
Other areas of specialty/work
Street address
Women Hospital- North Ostad Nejatollahi- Karim khan Zand bridge-Villa Street
City
Tehran
Postal code
Phone
+98 21 4216 0000
Fax
Email
fatedavtanha@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate Professor of OBS & GYN
Other areas of specialty/work
Street address
Women Hospital-North Ostad Nejatollahi- Karim Khan Zand Bridge-Villa street
City
Tehran
Postal code
Phone
+98 21 4216 0000
Fax
Email
fatedavtanha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate Professor of TUMS
Other areas of specialty/work
Street address
Women hospital on what olla hi avenue-Villa street
City
Tehran
Postal code
15978
Phone
+98 21 4216 0000
Fax
Email
fatedavtanha@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)