Threatened Preterm LaborPTLNCT01773135
Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor
An observational study of Threatened Preterm Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor . Read more about this study
- Who is it for?
- Ages 17 to 35 years, women only
- Conditions the study is for
- Threatened Preterm Labor
- What is being tested?
- collection of blood sample and tocolysis adminstration
- Type of treatment
- Pill or oral medicine
- How many people
- 262 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Jan 2014
- How long will I take part?
- 9 Weeks
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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%.
Who cannot join
- 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.
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- Fetal anomalies.
- IUGR.
- Smoking.
- Clinical signs of intrauterine infection eg (uterine tenderness, foul vaginal discharge, maternal pyrexia ≥ 38°C and/or maternal leucocytosis).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor .
Read the 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.
- Conditions
- Threatened Preterm Labor
- Being tested
- collection of blood sample and tocolysis adminstration
- Keywords
- threatened preterm labor, ACTH, PTL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of blood sample and tocolysis adminstrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: collection of blood sample and tocolysis adminstration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Threatened Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 262 participants (actual)
- Target duration
- 9 Weeks
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saied Eldein El-Safty, Ain Shams Maternity Hospital
- Investigators
- Mohamed S. Elsafty, M.D., Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773135
- Sponsor's protocol ID
- mai-01110333535
- Other IDs
- MAI-01110333535m
- Acronym
- PTL
- Status last verified
- Feb 2014
- First submitted
- 15 Jan 2013
- Last updated
- 3 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor
- ClinicalTrials.gov ID
- NCT01773135
- Acronym / sponsor ID
- PTL / mai-01110333535
- Conditions
- Threatened Preterm Labor
- Keywords
- threatened preterm labor, ACTH, PTL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 3 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm group | – | Other: collection of blood sample and tocolysis adminstrationpregnant 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) |
| full term group | – | Other: collection of blood sample and tocolysis adminstrationpregnant 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) |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (10 listed)
- Preterm rupture of membranes.
- Any uterine anomalies or cervical incompetence.
- Chronic illness such as chronic hypertension or kidney disease.
- Diabetes mellitus.
- Abruptio placenta.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of blood sample and tocolysis adminstrationinvestigators 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. | Other | full term group, preterm group |
Primary outcome
Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed S. Elsafty, M.D. principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Threatened Preterm Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.