Health Condition 1: O269- Pregnancy related conditions, unspecified
Conditions
Interventions
Intervention1: Lipocal microencapsulated calcium: 500mg once daily from 20th week ANC visit to till childbirth / parturition (Total duration of intervention is 20 weeks)
Control Intervention1: Shelcal
Sponsors
G.C Chemie Pharmie Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant females between the ages of >=18 and 40 years (both inclusive) willing to participate in study and provide written informed consent. 2. Pregnant women at 20th weeks attending antenatal care visit (ANC) visit at study clinics.
Exclusion criteria
Exclusion criteria: 1. No medical contraindications to continuing pregnancy. 2. Treatment with antitubercular and anti-epileptic drugs. 3. History of pre-eclampsia & eclampsia 4. History or signs and/or symptoms of nephrolithiasis 5. Prior diagnosis of parathyroid disorder or thyroidectomy 6. Diseases that require digoxin, phenytoin, or tetracycline therapy 7. History of chronic liver disease 8. History of renal disease & no known uterine anomaly 9. No history of cervical conization 10. Obesity (BMI 30.0 and higher) 11. Diagnostic history of Type I & Type II Diabetes 12. Diagnostic history of hypertension 13. History of any autoimmune disease 14. Subject with multiple pregnancy. 15. Diagnostic history of fetal anomalies. 16. Any other condition that in the opinion of the investigator does not justify the patients participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Modified Bovenschen GI Symptoms Questionnaire 2. Tolerability assessed via a five-point Facial Hedonic Scale for Taste (palatability) Swallowability Mouthfeel (texture) & SmellTimepoint: 1. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9. 2. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bristol Stool QuestionnaireTimepoint: visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9;Early preterm birthTimepoint: Start of study and up to 32 weeks;Information of any diagnosed preeclampsia during unscheduled ANC visitTimepoint: visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8 and visit 9.;IUGRTimepoint: visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9.;Low birth weightTimepoint: Throughout the study;Neonatal deathTimepoint: visit 9;Perinatal deathTimepoint: visit 6, visit 7, visit 8 and visit 9;Placental abruption with gradeTimepoint: Throughout the study;Preeclampsia Timepoint: visit 1, visit 5, visit 6, visit 7, visit 8, visit 9.;Preterm BirthTimepoint: Throughout the study;Small for gestational age birthTimepoint: visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9;Still birthTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactSubham Dutta
G.C Chemie Pharmie Limited
Outcome results
None listed