Health Condition 1: O141- Severe pre-eclampsia Health Condition 2: O365- Maternal care for known or suspected poor fetal growth Health Condition 3: P95- Stillbirth Health Condition 4: O601- Preterm labor with preterm delivery Health Condition 5: O45- Premature separation of placenta [abruptio placentae]
Conditions
Interventions
Intervention1: Two-step contingent screening model for identifying women (maternal clinical factors followed by biophysical and biochemical parameters) at high risk of GOS: The intervention is the two
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: a) Pregnant women with a singleton pregnancy b) Gestational age less than 13 plus 6 weeks confirmed by dating ultrasound c) Willingness to participate in the study and provide written informed consent
Exclusion criteria
Exclusion criteria: The pregnant women fulfilling the inclusion criteria will be excluded if they have any one of the following a) Women taking low dose aspirin regularly b) Pregnancies complicated by major fetal abnormality identified at the 11 to 13 weeks assessment c) Bleeding disorders such as Von Willebrand disease d) Peptic ulceration e) Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication f) Age less than 18 years g) Concurrent participation in another drug trial or at any time within the previous 28 days h) Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is a composite of GOS defined as the occurrence of one or more of the following adverse obstetric outcomes Preeclampsia or PE Fetal growth restriction or FGR Early or late fetal death or antepartum stillbirth Spontaneous preterm birth or sPTB Abruptio placentaeTimepoint: Primary outcome is a composite of GOS defined as the occurrence of one or more of the following adverse obstetric outcomes a) Preeclampsia (PE) The outcome assessments will begin at 20 to 24 weeks gestation and continue at scheduled antenatal visits b) Fetal Growth Restriction (FGR) Ultrasound assessments for fetal biometry and Doppler studies (including UAPI & UtAPI) will be performed starting at 20 to 24 weeks gestation and continue 4 weekly till 28 weeks, 2 weekly till 36 weeks and weekly till delivery c) Antepartum Stillbirth Any time after 20 weeks gestation until onset of labor or time of delivery d) Spontaneous preterm birth at delivery anytime between 22 weeks gestation until less than 37 completed weeks of gestation e) Abruptio Placentae Any time after 20 weeks of gestation until delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes Postpartum hemorrhage Maternal deathTimepoint: a) PPH i) From delivery until 24 hours postpartum (primary PPH) ii) Up to 6 weeks postpartum if secondary PPH included b) Maternal death Any time from enrollment (confirmation of pregnancy at less than 14 weeks) until 42 days postpartum;Neonatal outcomes Any NICU admission Neonatal deathTimepoint: a) NICU admission From birth until initial neonatal hospital discharge d) Neonatal death From birth until 28 completed days of life | — |
Countries
India
Contacts
Public ContactDr Nitya Wadhwa
All India Institute of Medical Sciences (AIIMS), Delhi
Outcome results
None listed