Intra-amniotic Subclinical Infection.NCT02104791
Evaluation of the Role of Plasma Procalcitonin in Prediction of Intra-amniotic Infection in Preterm Premature Rupture of Membrane
An observational study of Intra-amniotic Subclinical Infection., run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intra-amniotic Subclinical Infection.
- What is being tested?
- procalcitonin
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study population * This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014. * This study will include 100 pregnant women these cases will be divided into 2 groups: * Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age . * Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age.
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Procalcitonin Has a Role to Play in Prediction of Intra-amniotic Subclinical Infection.
It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection.
Read the detailed description
Study population
- This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014.
- This study will include 100 pregnant women these cases will be divided into 2 groups:
- Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
- Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age
- Conditions
- Intra-amniotic Subclinical Infection.
- Being tested
- procalcitonin
- Keywords
- Procalcitonin, intra-amniotic subclinical infection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitoninDrug
Also called plasma
In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?
| Study group | Role | What they receive |
|---|---|---|
| procalcitonin in blood | -Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age . Receives: Drug: procalcitonin | |
| plasma of blood | -Group 2: Preterm premature rupture of membrane Group include 50 pregnant women Receives: Drug: procalcitonin | |
| procalcitonin,prematureruptureofmembrane in blood | Complete history including (special habits like smoking and alcohol taking, menstrual history especially LMP, medical diseases, past obstetric history including duration, mode of delivery for each pregnancy, and if there were fetal or maternal complications).
Physical examination including (general condition, height, weight, vital signs).-Ultrasound to execlude multiple pregnancies, IUFD and to confirm oligohydraminos in group2.
The venous blood samples will be taken for measuring of -Procalcitonin in mothors -CRP and WBCs in mothers to detect infection -CRP in neonates of mothers of group 2.
They will be asked for their permission and consent. Receives: Drug: procalcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates.
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates
Measured: one year
Secondary outcomes (1)
Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.
Procalcitonin.
- C-reactive protein.
- White blood cells count (total and diffrantiated).
- C-reactive protein in neonates of groub 2.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra-amniotic Subclinical Infection.Studies 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Sayed Hassanin, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104791
- Sponsor's protocol ID
- MRCOG-1988
- Status last verified
- Apr 2014
- First submitted
- 2 Apr 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oludag T, Gode F, Caglayan E, Saatli B, Okyay RE, Altunyurt S. Value of maternal procalcitonin levels for predicting subclinical intra-amniotic infection in preterm premature rupture of membranes. J Obstet Gynaecol Res. 2014 Apr;40(4):954-60. doi: 10.1111/jog.12273. Epub 2013 Dec 10.
PubMed 24320627
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Has a Role to Play in Prediction of Intra-amniotic Subclinical Infection.
- ClinicalTrials.gov ID
- NCT02104791
- Acronym / sponsor ID
- MRCOG-1988
- Conditions
- Intra-amniotic Subclinical Infection.
- Keywords
- Procalcitonin, intra-amniotic subclinical infection.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection.
Detailed description
Study population
- This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014.
- This study will include 100 pregnant women these cases will be divided into 2 groups:
- Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
- Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| procalcitonin in blood | – | Drug: procalcitonin-Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age . |
| plasma of blood | – | Drug: procalcitonin-Group 2: Preterm premature rupture of membrane Group include 50 pregnant women |
| procalcitonin,prematureruptureofmembrane in blood | – | Drug: procalcitoninComplete history including (special habits like smoking and alcohol taking, menstrual history especially LMP, medical diseases, past obstetric history including duration, mode of delivery for each pregnancy, and if there were fetal or maternal complications). Physical examination including (general condition, height, weight, vital signs).-Ultrasound to execlude multiple pregnancies, IUFD and to confirm oligohydraminos in group2. The venous blood samples will be taken for measuring of -Procalcitonin in mothors -CRP and WBCs in mothers to detect infection -CRP in neonates of mothers of group 2. They will be asked for their permission and consent. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population * This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014. * This study will include 100 pregnant women these cases will be divided into 2 groups: * Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age . * Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| procalcitoninAlso: plasmaIn patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection? | Drug | plasma of blood, procalcitonin in blood, procalcitonin,prematureruptureofmembrane in blood |
Primary outcome
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates.
Time frame: one year
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates
1 secondary outcome
Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
- Results publication: PubMed 24320627Oludag T, Gode F, Caglayan E, Saatli B, Okyay RE, Altunyurt S. Value of maternal procalcitonin levels for predicting subclinical intra-amniotic infection in preterm premature rupture of membranes. J Obstet Gynaecol Res. 2014 Apr;40(4):954-60. doi: 10.1111/jog.12273. Epub 2013 Dec 10.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intra-amniotic Subclinical Infection., 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 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?
Results are not available in the source record.
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?
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02104791, which also lists 1 linked publication.
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 4 Apr 2014.