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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201503037974N7 |
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Date of registration:
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2015-06-28 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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In vivo performance of two commercial products of dinoprostone vaginal tablet and safety study of Kleen enema.
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Scientific title:
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In vivo performance of two commercial products of dinoprostone vaginal tablets and safety study of phosphate enema in pregnant women. |
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Date of first enrolment:
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2014-03-20 |
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Target sample size:
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90 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/8404 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: this is a single blind, two arm, parallel, randomized control study for dinoprostone. While for Kleen enema it is a single arm non-randomize study.
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Phase:
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2-3
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Mr. Salman A. Rahim
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Address:
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510, 5th floor, commerce center, Hasrat Mohani Road
74200
Karachi
Pakistan |
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Telephone:
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00922132636919 |
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Email:
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salman.rahim@nabiqasim.com |
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Affiliation:
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Nabiqasim Industries (Pvt) Ltd. |
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Name:
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Dr. Haleema Yasmin
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Address:
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Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road
75510
Karachi
Pakistan |
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Telephone:
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00922199201300 |
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Email:
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dr.haleemayasmin@yahoo.com |
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Affiliation:
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Department of Gynae and obstt at Jinnah postgraduate medical center |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclussion Criteria: pregnant women at or near term gestation (= 37 weeks) with a medical or obstetrical indication for the induction of labor; Age: 18-35 years; singleton pregnancy with cephalic presentation; parity = 3; intact membrane; bishop score less than or equal to 4; fetal reactive non-stress test.
Exclusion criteria: neuropathy; renal impairment; liver disease; diabetes; hypertension & CV disease; placenta previa; placental abruption; vasa previa; active herpes genitalia; spontaneous labour; fetal death in-utero; where oxytocic drugs are contraindicated or where prolong contractions of uterus are considered inappropriate.
kleen enema will not be administered if subject is with diarrhoea & vomiting .
Exclusion criteria:
Age minimum:
18 years
Age maximum:
35 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy, childbirth and the puerperium.
The codes included in this chapter are to be used for conditions related to or aggravated by the pregnancy, childbirth or by the puerperium (maternal causes or obstetric causes)
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The codes included in this chapter are to be used for conditions related to or aggravated by the pregnancy, childbirth or by the puerperium (maternal causes or obstetric causes)
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Intervention(s)
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Dinoprostone 3mg vaginal tablet (Reference Product: Prostin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours.
And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing.
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Dinoprostone 3mg vaginal tablet (Test Product: Glandin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours.
And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing.
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Intervention 1: Dinoprostone 3mg vaginal tablet (Test Product: Glandin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours.
And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing. Intervention 2: Dinoprostone 3mg vaginal tablet (Reference Product: Prostin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours.
And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing.
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Treatment - Drugs
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Primary Outcome(s)
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Cervical dilatation i.e. an increase of 3 in bishop from baseline. Timepoint: At six hours and 12 hours after dosing. Method of measurement: Bishop scoring.
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Cervical dilatation i.e. Attainment of bishop score of 6 or more. Timepoint: At six hours and 12 hours after dosing. Method of measurement: Bishop scoring.
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Kleen enema Adverse events. Timepoint: within half an hour after Kleen Enema dosing (before Dinoprostone Vaginal dosing). Method of measurement: Adverse event monitoring by subject monitoring.
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Vaginal delivery. Timepoint: Vaginal delivery occurring within 12 hours of dinoprostone dosing. Method of measurement: through Observation.
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Secondary Outcome(s)
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Maternal adverse events. Timepoint: after dosing till delivery for dinoprostone. and after phosphate enema dosing till before the dosing of dinoprostone. Method of measurement: through adverse event monitoring.
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Fetal Adverse events. Timepoint: After Dinoprostone vaginal tablet dosing till delivery. Method of measurement: CTG & obstetrical examination.
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Neonatal adverse events. Timepoint: Just after birth at 1 & 5 minutes. Method of measurement: APGAR score.
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Secondary ID(s)
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U1111-1167-6717
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Source(s) of Monetary Support
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Nabiqasim Industries (Pvt) Ltd.
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Jinnah Postgraduate Medical Center
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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