Ain Shams University, Maternity Hospital
Cairo, Egypt
NCT Number: NCT02697331
Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix .
Study Design:
The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).
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Notify Me18 year–45 year
Female
Interventional
Phase 3
Cairo, Egypt
Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix .
Study Design:
The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).
Inclusion criteria
( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include:
Exclusion criteria
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 - Cervical cerclage in place or planned . 2- on tocolytic drugs . 3- medically indicated preterm delivery < 35w of gestation . 4- known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) .
5- known contraindication to progesterone
women will receive progesterone vaginal pesarries containing 200mg of progesterone twice daily . it will be used by the patient as one vaginal pessary per vagina twice per day .
women will be showed how to use tablets . medication will be started at 20 -24 weeks and stopped at 36+6 weeks
Other names: uterocare
women will receive placebo pessary twice a day. women will be showed how to use tablets . medication will be started at 20-24 weeks and stopped at 36+6 weeks
Time frame: 37 weeks gestation determined by 12 weeks dating scan
Preterm birth
Time frame: From date of delivery to date of hospital discharge up to 28 days
admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis
Time frame: less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks
preterm delivery
Time frame: From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner
Drug adverse effects
Ain Shams University
Other
Evaluation of the Role of Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: Randomised Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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