Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

Study Overview
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Brief Summary
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How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

Detailed Description
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Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids

Official Title
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Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial

Conditions
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Preeclampsia

Intervention / Treatment
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* Procedure: Delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation Exclusion Criteria: Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg) Persistent symptoms of preeclampsia Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema) Fetal death, restriction of fetal grown
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Expectant management<br>Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. | |
| Active Comparator: Interventionist management<br>Interventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours. | Procedure: Delivery<br>* Termination of pregnancy (delivery)after completed corticosteroids<br>* Other names: expectant management of severe preeclampsia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal death | Number of perinatal in each group (interventionist or expectant management) | After begining the randomization until 4 weeks after delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal complications and maternal complications |  | Maternal and perinatal complication after begining the randomization until 4 weeks after delivery. |