# MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS

> **NIH NIH U10** · UNIVERSITY OF TENNESSEE HEALTH SCI CTR · 1994 · $423,166

## Abstract

Pregnancies complicated by preeclampsia remote from term are associated
with increased morbidity for both mother and fetus.  Most of the
perinatal risks are related to low-birth weight (premature and small for
gestational age).  Additionally, the mother is at increased risk for
significant cardiovascular, renal and cerebral morbidity.  Recent
advances in perinatal care has led to substantial improvement in
maternal outcome, however, the degree of improvement in perinatal
outcome has been less impressive.  The purpose of the present study is
to determine the clinical value of B-blocker therapy in preterm (<36
weeks' gestation) pregnancies complicated by mild preeclampsia.
Labetalol was selected as the B-blocker of choice because of the
favorable experience previously reported on its use in preeclampsia.
Four hundred patients will be randomly allocated in a double blind
fashion to treatment with either labetalol or placebo.  Labetalol will
be used to lower maternal blood pressure below 140 mm Hg systolic and
below 90 mm Hg diastolic in an attempt to prevent progression to severe
preeclampsia, to improve uteroplacental blood flow and prolong
gestation. Patient will be enrolled into the study between 26 to 36
weeks' gestation and will remain hospitalized until delivery. Each
patient will have intensive
maternal and fetal evaluation of well-being through the course of the
study.  The clinical value of this treatment will be judged on the basis
of the following outcome variables: (1) perinatal mortality; (2)
immediate neonatal and subsequent infant morbidity; (3) maternal
morbidity, (4) extent of maternal and neonatal hospitalization (5)
monetary costs of management for both mother and infant.  The
interpretation of the results will include a critical analysis of
risk/benefit ratios as well as the cost effectiveness of the treatment
plan.  It is hoped that the results of this trial can be applied
clinically to improve maternal and perinatal outcome in pregnancies
complicated by preeclampsia.

## Key facts

- **NIH application ID:** 2198271
- **Project number:** 5U10HD021414-09
- **Recipient organization:** UNIVERSITY OF TENNESSEE HEALTH SCI CTR
- **SAM.gov UEI:** X1M1PN3KG3E7
- **Principal Investigator:** BAHA M SIBAI
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1994
- **Award amount:** $423,166
- **Award type:** 5
- **Project period:** 1991-04-01 → 1996-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/2198271

## Citation

> US National Institutes of Health, RePORTER application 2198271, MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS (5U10HD021414-09). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/2198271. Licensed CC0.

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