Trial Outcomes & Findings for Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor (NCT NCT01773135)
NCT ID: NCT01773135
Last Updated: 2014-04-03
Results Overview
measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor
Recruitment status
COMPLETED
Target enrollment
262 participants
Primary outcome timeframe
9 weeks
Results posted on
2014-04-03
Participant Flow
Participant milestones
| Measure |
Pregnant Women With Threatened Preterm Labor
pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \> 1 and \< 4 cm, and/or Cervical effacement ≥ 80%.
then, collection of blood sample and tocolysis adminstration will be done
investigators obtained a blood sample from all patient to measure the serum level of ACTH.
all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.
After delivery, investigators devide the pateints into 2 groups (full term delivery \& preterm delivery) and investigators compare between these 2 groups by level of hormone.
|
|---|---|
|
Overall Study
STARTED
|
262
|
|
Overall Study
COMPLETED
|
262
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor
Baseline characteristics by cohort
| Measure |
Preterm Group
n=161 Participants
pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.
investigators obtained a blood sample from all patient to measure the serum level of ACTH.
all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.
this group delivered preterm (before 37 weeks of gestation)
|
Full Term Group
n=101 Participants
pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.
investigators obtained a blood sample from all patient to measure the serum level of ACTH.
all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.
this group delivered full term (after 37 weeks of gestation)
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
26 years
n=7 Participants
|
26 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
gestational age at admission
|
31 weeks
n=5 Participants
|
31 weeks
n=7 Participants
|
31 weeks
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeksmeasurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor
Outcome measures
| Measure |
Preterm Group
n=161 Participants
group of patients who delivered before 37 weeks of gestation
|
Full Term Group
n=101 Participants
group of patients who delivered after 37 weeks of gestation
|
|---|---|---|
|
Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor
|
23.4 pg/ml
Interval 19.2 to 29.0
|
19.3 pg/ml
Interval 16.7 to 21.5
|
Adverse Events
Pregnant Women With Threatened Preterm Labor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mohamed Saied Eldein El-Safty, Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams
Ain Shams University Maternity Hospital
Phone: 01003922211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place