Premature Birth
Conditions
Keywords
Preterm birth, Low dose aspirin
Brief summary
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).
Detailed description
Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the developed and developing world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially. Hypothesis: The investigators' primary hypothesis is that nulliparous women with no more than two previous first trimester pregnancy losses who are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) through 36 0/7 weeks GA will reduce the risk of preterm birth from all causes. Study Design Type: Prospective randomized, placebo-controlled, double-blinded multicenter clinical trial (patient level 1:1). Population: Nulliparous women between the ages of 18 (or local age of majority) and 40 with no more than two previous first trimester pregnancy losses or any second trimester spontaneous pregnancy loss, a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks GA confirmed by ultrasound, and no contraindications to aspirin. Other medical conditions, such as sickle-cell anemia, may be considered a contraindication per the judgment of the site investigator. Intervention: Daily administration of low dose (81 mg) aspirin \[also known as acetylsalicylic acid (ASA)\], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly. Outcomes: The primary outcome is to determine whether daily LDA initiated between 6 0/7 weeks and 13 6/7 weeks and continued to 36 0/7 weeks reduces the risk of preterm birth (birth prior to 37 0/7 weeks of pregnancy) by 20%. This will be determined based on assessed date of delivery in comparison to the projected estimated date of delivery, independent of whether or not the preterm delivery is indicated or spontaneous. Secondary outcomes include: * Preeclampsia and eclampsia (hypertensive disorders of pregnancy) * Small for gestational age * Perinatal mortality Other secondary outcomes of interest are: Maternal outcomes: * Vaginal bleeding * Antepartum hemorrhage * Postpartum hemorrhage * Maternal mortality * Late abortion * Change in maternal hemoglobin * Preterm, preeclampsia Fetal outcomes: * Preterm birth \<34 0/7 weeks of pregnancy * Birth weight \<2500g and \<1500g * Fetal loss * Spontaneous abortion * Stillbirth * Medical termination of pregnancy
Interventions
DRUGLow dose aspirin
Daily administration of low dose (81 mg) aspirin \[also known as acetylsalicylic acid (ASA\], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.
DRUGPlacebo
Placebo
Sponsors
Thomas Jefferson University
Jawaharlal Nehru Medical College
NICHD Global Network for Women's and Children's Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Nulliparous women between 18 - 40 years of age. Minors who are ≥ 14 years of age may be enrolled if permitted by the country's ethical guidelines. * No more than two previous first trimester pregnancy losses * No medical contraindications to aspirin; * Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat.
Exclusion criteria
* Women prescribed daily aspirin for more than 7 days; * Multiple gestations; * Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.); * Hemoglobin \< 7.0 gm/dl at screening; * Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, or any other known significant disease) * Blood pressure ≥ 140/90 (Systolic blood pressure ≥ 140 and diastolic ≥ 90 at screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Preterm Birth | At delivery | The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypertensive Disorders of Pregnancy | Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth) | \- Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy. |
| Incidence of Small for Gestational Age (SGA) | At delivery or at Day 42 after delivery | \- Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard |
| Incidence of Perinatal Mortality | At delivery or at Day 42 after delivery | \- Incidence of Perinatal Mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal Outcome 5 - Incidence of Late Abortion | At delivery or at Day 42 after delivery | \- Incidence of Late Abortion |
| Maternal Outcome 6 - Change in Maternal Hemoglobin | At enrollment, 4 weeks post enrollment, and 26-30 weeks GA. | Hemoglobin \< 7.0 gm/dl at 26-30 weeks gestation or a drop of 3.5+ gm/dl from screening to 26-30 weeks gestation |
| Maternal Outcome 7 - Incidence of Preterm, Preeclampsia | At delivery or at Day 42 after delivery | Early preterm delivery (\<34 weeks) and hypertensive disorders (i.e.: preeclampsia) |
| Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks) | At delivery | \- Early preterm delivery (\<34 weeks) |
| Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g | At delivery | \- Birth weight \<2500g |
| Maternal Outcome 1 - Incidence of Vaginal Bleeding | At delivery or at Day 42 after delivery | \- Vaginal bleeding |
| Fetal Outcome 4 - Incidence of Fetal Loss | At delivery | \- Incidence of Fetal Loss |
| Fetal Outcome 5 - Incidence of Spontaneous Abortion | At delivery | \- Incidence of Spontaneous Abortion |
| Fetal Outcome 6 - Incidence of All Stillbirth | At delivery | \- Incidence of All stillbirth |
| Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy | At delivery | \- Incidence of Medical Termination of Pregnancy |
| Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g | At delivery | \- Birth weight \<1500g |
| Maternal Outcome 2 - Incidence of Antepartum Hemorrhage | At delivery or at Day 42 after delivery | \- Antepartum hemorrhage |
| Maternal Outcome 3 - Incidence of Postpartum Hemorrhage | At delivery or at Day 42 after delivery | \- Postpartum hemorrhage |
| Maternal Outcome 4 - Incidence of Maternal Mortality | At delivery or at Day 42 after delivery | \- Incidence of Maternal Mortality |
Countries
Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, United States, Zambia
Participant flow
Recruitment details
Randomized, multi-country, double-masked, placebo-controlled trial of low-dose aspirin (81 mg daily) initiated between 6 weeks and 0 days of pregnancy, and 13 weeks and 6 days of pregnancy, in nulliparous women with an ultrasound confirming gestational age and a singleton viable pregnancy.
Pre-assignment details
Participants were randomly assigned (1:1, stratified by site) to receive aspirin or placebo tablets of identical appearance, via a sequence generated centrally by the data coordinating center.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Daily administration of low dose (81 mg) aspirin \[also known as acetylsalicylic acid (ASA\], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA. | 5,787 |
| Placebo Arm Identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery. | 5,771 |
| Total | 11,558 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 30 |
Baseline characteristics
| Characteristic | Intervention Arm | Total | Placebo Arm |
|---|---|---|---|
| Age, Customized Maternal Age (years) 20-29 years | 3429 Participants | 6801 Participants | 3372 Participants |
| Age, Customized Maternal Age (years) <20 years | 2233 Participants | 4506 Participants | 2273 Participants |
| Age, Customized Maternal Age (years) >29 years | 125 Participants | 251 Participants | 126 Participants |
| Antenatal care visits | 5 visits | 5 visits | 5 visits |
| Delivery attendant Family, self, or other acquaintance | 142 Participants | 289 Participants | 147 Participants |
| Delivery attendant Missing | 3 Participants | 7 Participants | 4 Participants |
| Delivery attendant Nurse or midwife | 2240 Participants | 4479 Participants | 2239 Participants |
| Delivery attendant Physician | 2938 Participants | 5846 Participants | 2908 Participants |
| Delivery attendant Traditional birth attendant | 464 Participants | 937 Participants | 473 Participants |
| Delivery location Clinic or health care | 1818 Participants | 3583 Participants | 1765 Participants |
| Delivery location Home or other | 488 Participants | 997 Participants | 509 Participants |
| Delivery location Hospital | 3479 Participants | 6973 Participants | 3494 Participants |
| Delivery location Missing | 2 Participants | 5 Participants | 3 Participants |
| Delivery mode Caesarean section | 1523 Participants | 2963 Participants | 1440 Participants |
| Delivery mode Medical termination of pregnancy | 5 Participants | 9 Participants | 4 Participants |
| Delivery mode Miscarriage | 0 Participants | 0 Participants | 0 Participants |
| Delivery mode Missing | 2 Participants | 5 Participants | 3 Participants |
| Delivery mode Vaginal | 4257 Participants | 8581 Participants | 4324 Participants |
| Maternal body-mass-index | 21.0 kg/m^2 STANDARD_DEVIATION 3.8 | 21.0 kg/m^2 STANDARD_DEVIATION 3.7 | 21.0 kg/m^2 STANDARD_DEVIATION 3.6 |
| Maternal Education >= 13 years of schooling | 629 Participants | 1261 Participants | 632 Participants |
| Maternal Education 1-6 years of schooling | 857 Participants | 1713 Participants | 856 Participants |
| Maternal Education 7-12 years of scholling | 3470 Participants | 6924 Participants | 3454 Participants |
| Maternal Education Missing | 1 Participants | 2 Participants | 1 Participants |
| Maternal Education No formal schooling | 830 Participants | 1658 Participants | 828 Participants |
| Maternal Height | 153.1 cm STANDARD_DEVIATION 6.9 | 153.1 cm STANDARD_DEVIATION 7 | 153.1 cm STANDARD_DEVIATION 7 |
| Maternal Weight | 49.3 kg STANDARD_DEVIATION 8.9 | 49.2 kg STANDARD_DEVIATION 8.8 | 49.2 kg STANDARD_DEVIATION 8.7 |
| Number of pregnancies 0 | 5274 Participants | 10500 Participants | 5226 Participants |
| Number of pregnancies 1 | 451 Participants | 920 Participants | 469 Participants |
| Number of pregnancies 2 | 62 Participants | 138 Participants | 76 Participants |
| Projected gestational age at enrollment | 10.1 weeks | 10.1 weeks | 10.1 weeks |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 5787 Participants | 11558 Participants | 5771 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Site Democratic Republic of the Congo | 655 Participants | 1320 Participants | 665 Participants |
| Site Guatemala | 836 Participants | 1671 Participants | 835 Participants |
| Site India (Belagavi) | 1327 Participants | 2650 Participants | 1323 Participants |
| Site India (Nagpur) | 1026 Participants | 2046 Participants | 1020 Participants |
| Site Kenya | 673 Participants | 1328 Participants | 655 Participants |
| Site Pakistan | 771 Participants | 1533 Participants | 762 Participants |
| Site Zambia | 499 Participants | 1010 Participants | 511 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 5,943 | 12 / 5,936 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 832 / 5,943 | 857 / 5,936 |
Outcome results
Primary
Incidence of Preterm Birth
The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous.
Time frame: At delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Incidence of Preterm Birth | 668 Participants |
| Placebo Arm | Incidence of Preterm Birth | 754 Participants |
Comparison: The null hypothesis is there is no treatment effect on preterm delivery.p-value: 0.01295% CI: [0.81, 0.98]Cochran-Mantel-Haenszel
Secondary
Incidence of Hypertensive Disorders of Pregnancy
\- Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy.
Time frame: Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Incidence of Hypertensive Disorders of Pregnancy | 352 Participants |
| Placebo Arm | Incidence of Hypertensive Disorders of Pregnancy | 325 Participants |
p-value: 0.29995% CI: [0.94, 1.25]Cochran-Mantel-Haenszel
Secondary
Incidence of Perinatal Mortality
\- Incidence of Perinatal Mortality
Time frame: At delivery or at Day 42 after delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Incidence of Perinatal Mortality | 264 Participants |
| Placebo Arm | Incidence of Perinatal Mortality | 309 Participants |
p-value: 0.04895% CI: [0.73, 1]Cochran-Mantel-Haenszel
Secondary
Incidence of Small for Gestational Age (SGA)
\- Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard
Time frame: At delivery or at Day 42 after delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Incidence of Small for Gestational Age (SGA) | 1506 Participants |
| Placebo Arm | Incidence of Small for Gestational Age (SGA) | 1564 Participants |
p-value: 0.17195% CI: [0.9, 1.01]Cochran-Mantel-Haenszel
Other Pre-specified
Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks)
\- Early preterm delivery (\<34 weeks)
Time frame: At delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks) | 189 Participants |
| Placebo Arm | Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks) | 230 Participants |
p-value: 0.03995% CI: [0.61, 0.93]Cochran-Mantel-Haenszel
Other Pre-specified
Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g
\- Birth weight \<2500g
Time frame: At delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g | 1078 Participants |
| Placebo Arm | Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g | 1153 Participants |
p-value: 0.07395% CI: [0.87, 1.01]Cochran-Mantel-Haenszel
Other Pre-specified
Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g
\- Birth weight \<1500g
Time frame: At delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g | 78 Participants |
| Placebo Arm | Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g | 101 Participants |
p-value: 0.08495% CI: [0.57, 1.33]Cochran-Mantel-Haenszel
Other Pre-specified
Fetal Outcome 4 - Incidence of Fetal Loss
\- Incidence of Fetal Loss
Time frame: At delivery
Population: ITT population; numbers reported reflect available data and therefore do not always reflect the total population defined in the ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Fetal Outcome 4 - Incidence of Fetal Loss | 303 Participants |
| Placebo Arm | Fetal Outcome 4 - Incidence of Fetal Loss | 353 Participants |
p-value: 0.03995% CI: [0.73, 1]Cochran-Mantel-Haenszel
Other Pre-specified
Fetal Outcome 5 - Incidence of Spontaneous Abortion
\- Incidence of Spontaneous Abortion
Time frame: At delivery
Population: ITT population; numbers reported reflect available data and therefore do not always reflect the total population defined in the ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Fetal Outcome 5 - Incidence of Spontaneous Abortion | 134 Participants |
| Placebo Arm | Fetal Outcome 5 - Incidence of Spontaneous Abortion | 152 Participants |
p-value: 0.26195% CI: [0.7, 1.1]Cochran-Mantel-Haenszel
Other Pre-specified
Fetal Outcome 6 - Incidence of All Stillbirth
\- Incidence of All stillbirth
Time frame: At delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Fetal Outcome 6 - Incidence of All Stillbirth | 141 Participants |
| Placebo Arm | Fetal Outcome 6 - Incidence of All Stillbirth | 166 Participants |
p-value: 0.14195% CI: [0.68, 1.06]Cochran-Mantel-Haenszel
Other Pre-specified
Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy
\- Incidence of Medical Termination of Pregnancy
Time frame: At delivery
Population: ITT population; numbers reported reflect available data and therefore do not always reflect the total population defined in the ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy | 42 Participants |
| Placebo Arm | Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy | 30 Participants |
p-value: 0.15795% CI: [0.88, 2.23]Cochran-Mantel-Haenszel
Other Pre-specified
Maternal Outcome 1 - Incidence of Vaginal Bleeding
\- Vaginal bleeding
Time frame: At delivery or at Day 42 after delivery
Population: ITT population; numbers reported reflect available data and therefore do not always reflect the total population defined in the ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Maternal Outcome 1 - Incidence of Vaginal Bleeding | 214 Participants |
| Placebo Arm | Maternal Outcome 1 - Incidence of Vaginal Bleeding | 246 Participants |
p-value: 0.12595% CI: [0.73, 1.04]Cochran-Mantel-Haenszel
Other Pre-specified
Maternal Outcome 2 - Incidence of Antepartum Hemorrhage
\- Antepartum hemorrhage
Time frame: At delivery or at Day 42 after delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Maternal Outcome 2 - Incidence of Antepartum Hemorrhage | 26 Participants |
| Placebo Arm | Maternal Outcome 2 - Incidence of Antepartum Hemorrhage | 25 Participants |
p-value: 0.995% CI: [0.6, 1.79]Cochran-Mantel-Haenszel
Other Pre-specified
Maternal Outcome 3 - Incidence of Postpartum Hemorrhage
\- Postpartum hemorrhage
Time frame: At delivery or at Day 42 after delivery
Population: Safety population (women receiving at least one dose of drug or placebo); numbers reported reflect available data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Maternal Outcome 3 - Incidence of Postpartum Hemorrhage | 54 Participants |
| Placebo Arm | Maternal Outcome 3 - Incidence of Postpartum Hemorrhage | 43 Participants |
p-value: 0.27495% CI: [0.84, 1.86]Cochran-Mantel-Haenszel
Other Pre-specified
Maternal Outcome 4 - Incidence of Maternal Mortality
\- Incidence of Maternal Mortality
Time frame: At delivery or at Day 42 after delivery
Population: ITT population; numbers reported reflect available data and therefore do not always reflect the total population defined in the ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Maternal Outcome 4 - Incidence of Maternal Mortality | 9 Participants |
| Placebo Arm | Maternal Outcome 4 - Incidence of Maternal Mortality | 12 Participants |
p-value: 0.51295% CI: [0.32, 1.78]Cochran-Mantel-Haenszel
Other Pre-specified
Maternal Outcome 5 - Incidence of Late Abortion
\- Incidence of Late Abortion
Time frame: At delivery or at Day 42 after delivery
Population: ITT population; numbers reported reflect available data and therefore do not always reflect the total population defined in the ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Maternal Outcome 5 - Incidence of Late Abortion | 23 Participants |
| Placebo Arm | Maternal Outcome 5 - Incidence of Late Abortion | 30 Participants |
p-value: 0.33195% CI: [0.45, 1.31]Cochran-Mantel-Haenszel
Other Pre-specified
Maternal Outcome 6 - Change in Maternal Hemoglobin
Hemoglobin \< 7.0 gm/dl at 26-30 weeks gestation or a drop of 3.5+ gm/dl from screening to 26-30 weeks gestation
Time frame: At enrollment, 4 weeks post enrollment, and 26-30 weeks GA.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Maternal Outcome 6 - Change in Maternal Hemoglobin | 290 Participants |
| Placebo Arm | Maternal Outcome 6 - Change in Maternal Hemoglobin | 333 Participants |
Other Pre-specified
Maternal Outcome 7 - Incidence of Preterm, Preeclampsia
Early preterm delivery (\<34 weeks) and hypertensive disorders (i.e.: preeclampsia)
Time frame: At delivery or at Day 42 after delivery
Population: Modified ITT; numbers reported reflect available data and therefore do not always reflect the total population defined in the mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Maternal Outcome 7 - Incidence of Preterm, Preeclampsia | 8 Participants |
| Placebo Arm | Maternal Outcome 7 - Incidence of Preterm, Preeclampsia | 21 Participants |
p-value: 0.01595% CI: [0.17, 0.85]Cochran-Mantel-Haenszel