Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor

Threatened Preterm Labor Clinical Trial

— PTL  

Official title:

Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773135
• Other study ID #: mai-01110333535
• Secondary ID: MAI-01110333535m
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: February 21, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 35 Years

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Threatened Preterm Labor

Intervention

Other:
• collection 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.

Locations

Country	Name	City	State
Egypt	Ainshams Maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	9 weeks	Yes