Threatened Preterm Labor
Conditions
Keywords
threatened preterm labor, ACTH, PTL
Brief summary
The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor .
Detailed description
This is a cross sectional study that will include 261 pregnant women aged between 17 and 35 years with singleton pregnancies between 28 and 36 completed weeks of gestation that had been diagnosed with threatened preterm labor and consented to participate in this study. This study will be conducted at Ain Shams University Maternity Hospital after approval of the research and ethics committee. the investigators include all patients which have these following criteria (Singleton pregnancy, Age between 17 - 35 years, Gestational age between 28 and 36 weeks and Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): 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%. the investigators exclude any patient which has any of the following criteria (Preterm rupture of membranes, Any uterine anomalies or cervical incompetence, Chronic illness such as chronic hypertension or kidney disease, Diabetes mellitus, Abruptio placenta, Preeclampsia and HELLP syndrome, Fetal anomalies, IUGR, Smoking or Clinical signs of intrauterine infection). blood sample was collected from each patient for measurement of ACTH level. According to local protocol in Ain Shams University Maternity Hospital all women will receive a fixed regimen of tocolysis in the form of nifedipine (Epilat) 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) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery. After delivery, the investigators divide the patients into 2 groups (full term delivery & preterm delivery) and we compare between these 2 groups by level of hormone.
Interventions
OTHERcollection of blood sample and tocolysis adminstration
investigators will abtain a blood sample from all patient to measure the serum level of ACTH. all patients with threatened preterm labor will receive 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) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. 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.
Sponsors
Ain Shams Maternity Hospital
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy. * Age between 17 - 35 years. * Gestational age between 28 and 36 weeks. * Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): 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%.
Exclusion criteria
* Preterm rupture of membranes. * Any uterine anomalies or cervical incompetence. * Chronic illness such as chronic hypertension or kidney disease. * Diabetes mellitus. * Abruptio placenta. * Preeclampsia and HELLP syndrome. * Fetal anomalies. * IUGR. * Smoking. * Clinical signs of intrauterine infection eg (uterine tenderness, foul vaginal discharge, maternal pyrexia ≥ 38°C and/or maternal leucocytosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor | 9 weeks | 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 |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preterm Group 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) | 161 |
| Full Term Group 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) | 101 |
| Total | 262 |
Baseline characteristics
| Characteristic | Preterm Group | Full Term Group | Total |
|---|---|---|---|
| Age, Continuous | 26 years | 26 years | 26 years |
| gestational age at admission | 31 weeks | 31 weeks | 31 weeks |
| Sex: Female, Male Female | 161 Participants | 101 Participants | 262 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor
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
Time frame: 9 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preterm Group | Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor | 23.4 pg/ml |
| Full Term Group | Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor | 19.3 pg/ml |
p-value: <0.001U statistic