Progesterone in Expectantly Managed Early-onset Preeclampsia
Ключови думи
Резюме
Описание
Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment
Дати
| Последна проверка: | 02/29/2020 |
| Първо изпратено: | 08/31/2019 |
| Очаквано записване подадено: | 08/31/2019 |
| Първо публикувано: | 09/03/2019 |
| Изпратена последна актуализация: | 03/22/2020 |
| Последна актуализация публикувана: | 03/24/2020 |
| Действителна начална дата на проучването: | 12/14/2019 |
| Приблизителна дата на първично завършване: | 05/31/2021 |
| Очаквана дата на завършване на проучването: | 09/30/2021 |
Състояние или заболяване
Интервенция / лечение
Drug: study group
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: study group women will be given 17-OHPC 250 mg intra-muscular at admission and every 7 days thereafter in addition to other conservative measures of early-onset PE | Drug: study group Intramuscular injection 250 mg |
| No Intervention: control group No intervention will be given apart from the usual conservative measures of early-onset PE |
Критерии за допустимост
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Gestational age between 20+0 and 33+6 weeks. - Singleton pregnancy. - Willing to participate in the study and sign the informed consent. Exclusion Criteria: - Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema). - Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations). - Platelet count < 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome; - Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values); - Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile); - Severe Oligohydramnios (AFI < 5cm) - Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing; - Eclampsia; - Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/or recurrent variable or late decelerations); - Intrauterine fetal death. - Patient is unable or unwilling to give consent. - Patients currently using progesterone for other indications. |
Резултат
Първични изходни мерки
1. The mean difference between blood pressure measurements in both groups [one month]
