Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01710384 |
| Other study ID # |
006111 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2
|
| First received |
October 17, 2012 |
| Last updated |
October 17, 2012 |
| Start date |
November 2012 |
| Est. completion date |
November 2015 |
Study information
| Verified date |
October 2012 |
| Source |
Meir Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
ISRAEL: PHARMACEUTICAL ADMINISTRATION. CLINICAL TRIALS DEPT. |
| Study type |
Interventional
|
Clinical Trial Summary
To test the effect on premature infants of a one-time course of betamethasone administered
in weeks 34-36 of gestation.
Description:
Protocol version 3, 1/7/2012
Research Goal To test the effect on premature infants of a one-time course of betamethasone
administered in weeks 34-36 of gestation.
Inclusion criteria
1. Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course
to enhance fetal lung maturity during pregnancy
2. Clinical, sonographic or laboratory suspicion of premature labor
3. Singleton or twin pregnancy Exclusion criteria
1. Premature rupture of membranes 2. Fetus with known defects 3. Suspicion of fetal distress
4. Betamethasone administered during pregnancy for any reason Research protocol Study group
100 women in weeks 34-36 of gestation with clinical, sonographic or laboratory suspicion of
early labor will be recruited.
Demographic data will be collected, including full medical and obstetrical anamnesis.
After full obstetric analysis, including monitoring, sonographic and lab tests as needed for
each case and as determined by department policy, a full course of 2 injections of
betamethasone will be given 24-hours apart.
After birth, data will be collected on the delivery, including birth week, method (vaginal,
cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature
rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1
and 5 minute Apgar scores, and complications during the first week of life, including
hypoglycemia, seizures, intubation or medications will also be collected.
Prospective control group 100 women will be recruited who delivered in the hospital during
the study period in weeks 34-37 of pregnancy, who did not receive a course of betamethasone
during pregnancy.
Demographic data will be collected, full medical and obstetric anamnesis including current
and previous pregnancies.
After birth, data will be collected on the delivery, including birth week, method (vaginal,
cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature
rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1
and 5 minute Apgar scores, and complications during the first week of life, including
hypoglycemia, seizures, intubation or medications will also be collected.
Data will be collected over a one-year period. Retrospective control group 200 women who
delivered from 2009 to 2011, in weeks 34-37 of gestation who did not receive a course of
betamethasone during the pregnancy.
Data will be anonymously collected from medical records, including demographics and full
medical and obstetric anamnesis.
After birth, data will be collected on the delivery, including birth week, method (vaginal,
cesarean, forceps, etc.), obstetric complications (abruption of the placenta, Premature
rupture of membranes, preeclampsia, etc.). Data on the neonate, including birth weight, 1
and 5 minute Apgar scores, and complications during the first week of life, including
hypoglycemia, seizures, intubation or medications will also be collected.
The pregnancy and neonatal outcomes among the groups of women who received and did not
receive betamethasone will be evaluated.
