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Maternal Studies

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Antenatal Corticosteroids Trial (ACT)

The ACT study is a multi-site, randomized controlled trial to reduce neonatal mortality by improving identification of women at risk of preterm delivery and increasing the use of antenatal corticosteroids. A multi-faceted intervention among health care providers will be tested in six middle and low-income countries.

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Safe Pregnancy Through Malaria Control in the Democratic Republic of Congo (DRC)

A study to assess the pharmacokinetics and pharmacodynamics of an orally-administered standard adult dose (200 mg) of artesunate, to determine if it is appropriate in parasitemic pregnant women when compared to the same women at three months postpartum and to parasitemic non-pregnant women.

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Antioxidant Therapy to Prevent Preeclampsia

A randomized, controlled trial testing whether the joint administration of the antioxidants vitamin C (1000mg) and vitamin E (400IU) would reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.

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RCT of Misoprostol for Postpartum Hemorrhage in India

A randomized controlled trial to assess the prophylactic effectiveness of oral misoprostol administered in the community to women in the third stage of labor to reduce the incidence of acute postpartum hemorrhage.

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Zhi Byed Versus Misoprostol

A prospective, double-masked randomized study to determine the effect of prophylactic oral ZB11 administered at the beginning of the second stage of labor vs. prophylactic oral misoprostol administered in the third stage of labor, in reducing the incidence of acute PPH among Tibetan women giving birth in three hospitals in Lhasa, TAR.

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Tobacco Use

To determine the prevalence of tobacco use (smoking and smokeless tobacco), the Global Network, in collaboration with the National Cancer Institute, conducted a cross-sectional survey of knowledge, attitudes and behaviors regarding tobacco use among pregnant women in nine countries.

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Emergency Obstetric and Neonatal Care (EmONC)

Three primary training components in the intervention clusters are 1) EmONC facility training to address the primary causes of maternal and perinatal mortality, 2) community mobilization training to increase birth planning and transport, and 3) Home-Based Life Saving Skills (HBLSS) to assist birth attendants in the identification and referral of complications during delivery.

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Birth Attendant Survey

Birth attendants were interviewed to assess training level, knowledge, skills, and access to medical equipment, and testing. The interaction of more than 100 home delivery attendants with their health care systems in 7 international sites in India, Pakistan, Guatemala, the Democratic Republic of the Congo, Kenya, and Zambia was also assessed. The study found that community birth attendants were often illiterate, could not read numbers, and had little formal training. They had limited skills and access to medications and equipment that are necessary to reduce maternal, fetal, or neonatal mortality.

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Tape for Assessing Gestational Age

Development and validation of a fundal height color-coded Tape for Assessing Gestational Age was conducted in 2 phases. First, an observational study was conducted to design a tape for fundal height measurement, which corresponds to a growth chart to identify pre-term pregnancies between 24 and 38 weeks. Three color-coded tapes, using region-specific upper and lower values of preterm gestational age were then designed and tested for the validity of identifying preterm pregnancies between 24-36 weeks of gestational age in Pakistan, India and Argentina. The tape is being used to identify women with unknown gestational ages who are eligible for the receipt of corticosteroids in ACT. A manuscript is in preparation.

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Verbal Autopsy

The verbal autopsy study examined cause of death (COD) for community-based perinatal deaths using a VA tool; COD assigned by non-physicians was comparable to physicians.

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First Look

Obstetric ultrasound is part of current antenatal care in high-resource settings and used to identify complications of pregnancy as well as to establish accurate gestational age. Ultrasound is increasingly being disseminated in low-resource settings due lower costs and increased durability of the equipment but its impact on maternal and newborn mortality in these settings has not been assessed.

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Women First

A study to test whether a nutrition intervention commencing at least 3 months before conception, will be associated with a greater newborn length compared to offspring whose mothers receive the same intervention at 12 weeks gestation or not at all.

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ASPIRIN

Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the developed and developing world. A growing body of evidence suggests that 1st trimester administration of low dose aspirin can reduce the rate of PTB substantially. This prospective, randomized, placebo-controlled, double-blinded, multi-center clinical trial will examine whether low dose aspirin initiated between 6 0/7 weeks- 12 6/7 weeks gestation reduces the risk of PTB.

Newborn Studies

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Clustered Trial for Improving Perinatal Care in Uruguay/Argentina

A cluster randomized controlled trial of a behavioral intervention in Argentina and Uruguay that will increase the use of two evidence-based birth practices (EBP), the selective use of episiotomies and active management of the third stage of labor.

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Neonatal Resuscitation in Zambia

To test training staff in the Neonatal Resuscitation Program and the WHO integrated Management of Pregnancy and Childbirth: Pregnancy, Childbirth, Postpartum and Newborn Care Guide for Essential Practice (2003): Essential Newborn Care Program (ENC) compared to training staff in the ENC alone will reduce neonatal mortality or stillbirth (7 days).

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Systematic Pediatric Care for Oral Clefts

Study of an intensive pediatric care intervention designed to reduce neonatal mortality of children born with oral clefts and to follow a subset of these who have been randomized into normal or more intensive pediatric care through two years.

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Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala

A randomized controlled trial comparing zinc supplementation to complementary feeding in infants between 6-12 months of age.

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Prevention of Infection in Indian Neonates

A study of the colonization ability of a probiotic supplement (Lactobacillus plantarum) in the infant gut.

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A Randomized trial of chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity

A randomized controlled trial to determine the efficacy of a vaginal/neonatal wash to reduce 28-day neonatal and maternal morbidity and mortality.

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First Breath

Almost 4,000 birth attendants from 100 GN communities with more than 150,000 deliveries were trained in neonatal care and resuscitation, using the WHO Essential Newborn Care training program, followed by randomization to the Neonatal Resuscitation Program. The trial significantly reduced perinatal deaths. As many as 30 to 40% of perinatal deaths may be averted with this simple intervention which led to the development of Helping Babies Breathe.

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Complementary Feeding (FIRST BITES)

The primary outcome measure was linear growth velocity; secondary outcomes were neurocognitive development, infectious disease morbidity, dietary diversity, and micronutrient status. The trial was conducted in 4 of the 7 Global Network sites (Guatemala, Pakistan, Zambia, and the Democratic Republic of the Congo).

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BRAIN

The BRAIN study is a recently completed randomized trial to evaluate the impact of a home-based, parent-provided early intervention on the neurodevelopmental outcome of infants who were resuscitated for mild to moderate asphyxia in the FIRST BREATH trial in Zambia, Pakistan, and Belgaum, India. All infants received case management and growth monitoring. Trained, certified staff masked to the infants' history conducted the neurodevelopmental testing, which was adapted for use in the relevant cultural context.

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Helping Babies Breathe (HBB)

The HBB initiative represents a further development of the Global Network FIRST BREATH trial, which was designed to provide skilled birth attendants to babies wherever they are born. HBB is being rolled out globally by the Global Network, the American Academy of Pediatrics, USAID and its partners, Saving Newborn Lives, Laerdal, Inc. It was field tested in 5 sites, 2 of which were Global Network sites in Kenya and Belgaum, India, and includes the development of a new low-cost neonatal simulator and resuscitation bag.

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