Trial · NCT01355159
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Preeclampsia | Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery) | PE is defined as diastolic blood pressure ≥90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20+0 weeks of gestation. Proteinuria is defined as: urinary protein ≥300mg in 24 hour urine collection OR in the absence of 24 hour collection, ≥2+ dipstick proteinuria, OR random protein-creatinine ratio ≥30mg protein/mmol. OR HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome defined as: Haemolysis (characteristic peripheral blood smear), Serum LDH ≥ 600U/L, Serum AST ≥ 70U/L, and Platelet count \<100 x109/L OR Superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria. |
| Secondary | Maternal Death | Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery) | According to the World Health Organization, "A maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. |
| Secondary | Spontaneous Abortion | Participants will be followed from randomization until 20+0 weeks of gestation | Spontaneous abortion or miscarriage defined as death of a fetus \<500g or \<20 weeks of gestation |
| Secondary | Placenta Abruption | Participants will be followed from 20+0 weeks of gestation until delivery | Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus. |
| Secondary | Premature Rupture of Membranes | Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor | Rupture of the membranes (rupture of the amniotic sac) before the onset of labor. |
| Secondary | Preterm Birth | Participants will be followed from 20+0 weeks to 36+6 weeks of gestation | Birth that occur earlier than 37+0 weeks of gestational age. |
| Secondary | HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count) | Participants will be followed from 20+0 weeks of gestation until delivery | Haemolysis (characteristic peripheral blood smear), Serum LDH \>=600U/L, Serum AST \>=70U/L, Platelet count \<100 x109/L |
| Secondary | Severe Preeclampsia | Participants will be followed from 20+0 weeks of gestation until delivery. | Severe PE: Defined as PE with convulsion or HELLP or delivery \<34 weeks. |
| Secondary | Antenatal Inpatient Length of Stay | Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery | Length of inpatient stay before admission for delivery in days |
| Secondary | Stillbirth | Participants will be followed from 20+0 weeks of gestation up to delivery. | Fetal death defined as death of fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation. |
| Secondary | Intrauterine Growth Restriction (<3rd Percentile) | Participants will be followed from 20+0 weeks of gestation until delivery | Intrauterine growth restriction is defined as a birth weight less than the 3rd percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard. |
| Secondary | Intrauterine Growth Restriction (<10th Percentile) | Participants will be followed from 20+0 weeks of gestation until delivery | Intrauterine growth restriction is defined as a birth weight less than the 10th percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard. |
| Secondary | Neonatal Death | Participants will be followed from birth until 28 days of life | Neonatal death defined as death of a baby that occurred during first 28 days of life. |
| Secondary | Perinatal Mortality | Participants will be followed from 20+0 weeks of gestation until 28 days of life. | The perinatal mortality is defined as the number of deaths (fetal deaths and neonatal deaths) of babies ≥ 500 grams birth weight or, if birth weight is unavailable, a gestational age ≥ 20+0 weeks, up to 28 completed days after birth. |
| Secondary | Retinopathy of Prematurity | Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks | Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity. |
| Secondary | Early Onset Sepsis | Infants born to the participants will be followed first 48 hours of life. | Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures |
| Secondary | Necrotising Enterocolitis | Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks. | Necrotizing enterocolitis (NEC) according to modified Bell's criteria stage 2 or higher (grossly bloody stool, plus absent bowel sounds with or without abdominal tenderness and radiographic findings such as intestinal dilation, ileus, pneumatosis intestinalis), excluding isolated spontaneous intestinal perforations. |
| Secondary | Intraventricular Hemorrhage (IVH) | Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks | * IVH Grade 1(Blood in germinal matrix) * IVH Grade 2 (Blood in germinal matrix and extending into the ventricles) * IVH Grade 3 (Ventricular enlargement) * IVH Grade 4 (Intraparenchymal lesion) |
| Secondary | Ventilation | Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks. | Ventilatory support after initial resuscitation, with/without intubation. |
| Secondary | Need for Oxygen at 28 Days | Infants to the participants will be followed for 28 days after birth. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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