Clinical trial NCT01773135: Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor
Official title: Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Threatened Preterm Labor
Keywords: threatened preterm labor
ACTH
PTL
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 262
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams Maternity hospital
Study officials:
affiliation: Ain Shams University
name: Mohamed S. Elsafty, M.D.
role: PRINCIPAL_INVESTIGATOR
References: