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IRCT20230117057148N1 IRCT 2023-04-06 Lady Reading Hospital Oral versus vaginal progestogens in women with recurrent miscarriages Progestogens for recurrent miscarriages trial Efficacy of oral versus vaginal progestogens in the maintenance of early pregnancy in women with recurrent miscarriages 2020-04-02 anticipated 108 Complete https://irct.ir/trial/68172 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the included patients were given code from 1-108, these codes were entered in the computer , through SPSS random numbers were generated. Computer itself divided numbers randomly in to 2 groups i.e 54 in one and 54 in other group. 4 recurrent miscarriages. Intervention 1: Interventional Group 1: This group will be given oral progestogens in a dose of 10mg twice a day in morning and evening after meals for 12 weeks. Efficacy will be measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will be performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity. This group will also serve as control as it is the standard routine route by which progestogens are given. Intervention 2: Intervention group 2: This group was prescribed vaginal progestogens in a dose of 200mg twice a day for 12 weeks. Efficacy was measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is do not want to break the confidentiality of patients
public Dr Laiyla Shinwari
House No. T-825, Street No. 5, Opposite
Peshawar Pakistan 25000 +92 332 9022886 drlailakhan@yahoo.com Lady Reading hospital scientific Dr Laiyla Shinwari
House No. T-825, Street No. 5, Opposite
Peshawar Pakistan 25000 +92 91 2583455 drlailakhan@yahoo.com Lady Reading hospital Pakistan Pregnancy Aged 16-40 years, A history of at least three recurrent miscarriages At or less than 7 weeks of gestational age 16 years 40 years Female Threatened miscarriage, Breast carcinoma Structural uterine abnormality distorting the cavity, Absence of fetal cardiac activity (missed abortion), Contraindications to progestron use (e.g. allergy to progesterone) Inadequate treatment compliance O03 Spontaneous abortion Treatment - Other Treatment - Other Interventional Group 1: This group will be given oral progestogens in a dose of 10mg twice a day in morning and evening after meals for 12 weeks. Efficacy will be measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will be performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity. This group will also serve as control as it is the standard routine route by which progestogens are given. Intervention group 2: This group was prescribed vaginal progestogens in a dose of 200mg twice a day for 12 weeks. Efficacy was measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity Pregnancy. Timepoint: 12 weeks of gestation. Method of measurement: ultrasound. Lady Reading Hospital Approved 2020-03-01 Ethics Committee of the college of physicians and surgeons Pakistan House No. T-825, Street No. 5, Opposite Peshawar Pakistan- Peshawar Pakistan