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

NCT01773135 | Completed Results DMC

• 2 other identifiers: mai-01110333535MAI-01110333535m
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Threatened Preterm Labor

Keywords

threatened preterm labor; ACTH; PTL

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

preterm group

pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened preterm labor 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%. collection of blood sample and tocolysis administration will be done this group will deliver preterm (before 37 weeks of gestation)

Other: collection of blood sample and tocolysis adminstration

full term group

pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened preterm labor 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%. collection of blood sample and tocolysis administration will be done this group will deliver full term (after 37 weeks of gestation)

Other: collection of blood sample and tocolysis adminstration

Interventions

collection of blood sample and tocolysis adminstration OTHER

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.

full term group; preterm group

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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%.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ainshams Maternity hospital

Cairo, Egypt, 133119, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Limitations and Caveats

It's the different time of day that blood sampling was carried out, although this reflects normal clinical practice, blood samples were collected at the time of admission to hospital regardless of the time of day, rather than diurnal pattern of ACTH.

Results Point of Contact

• Title: Mohamed Saied Eldein El-Safty, Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams
• Organization: Ain Shams University Maternity Hospital

dr.mai_elshahm@yahoo.com

01003922211

Study Officials

• Mohamed S. Elsafty, M.D.

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 9 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams University

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 23, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 3, 2014
• Results First Posted: April 3, 2014

Record last verified: 2014-02

Locations

EG (1)