Preterm Premature Rupture of MembranesNCT02635451
The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes
An observational study of Preterm Premature Rupture of Membranes, run by Ain Shams Maternity Hospital.
Trial summary
To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Premature Rupture of Membranes
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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 starting from January 2016. This study will include 40 pregnant women between 28-37 weeks were recruited.
Who may be able to join
- Singleton pregnancies
- Gestational age between 28-37 weeks
- Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal
Who cannot join
- Patients with multiple pregnancies
- Smoker
- Polyhydramnios
- Maternal diseases such as: anemia, diabetes, UTI, RTI and vaginal infection
- History of PPROM in previous pregnancies
- Evidence of chorioamnionitis in current pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.
Read the detailed description
The micronutrient vitamin C is an effective water soluble antioxidant that scavenges several reactive oxygen species, thus reducing oxidative stress, It also acts as an enzymatic cofactor to the enzymes lysyl hydroxylase and prolyl hydroxylase, which is required for synthesis of hydroxyproline and hydroxylysine, Collagen requires hydroxyproline bridges across the triple helix to provide stability to it, Ascorbic acid also causes down regulation of the metalloproteinase-2 and biosynthesis of collagen where it is required for the formation of triple helical structure of collagen. Thus, ascorbic acid participates in the equilibrium between synthesis and degradation of collagen and this may be critical in reducing the occurrence of preterm PROM.
- Conditions
- Preterm Premature Rupture of Membranes
- Keywords
- vitamin c, Preterm Premature Rupture of Membranes
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Study group included 20 pregnant women with PPROM and fulfilled the inclusion and exclusion criteria. | |
| control group | Control group also included 20 pregnant women without PPROM following every recorded case of PPROM and matched for gestational age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between serum vitamin C concentration and PPROM
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembranesStudies 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hussein Mostafa, Ain Shams Maternity Hospital
- Investigators
- Sherif M Habib, MD, Study director, Professor of Obstetric and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635451
- Sponsor's protocol ID
- MHMostafa
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT02635451
- Acronym / sponsor ID
- MHMostafa
- Conditions
- Preterm Premature Rupture of Membranes
- Keywords
- vitamin c, Preterm Premature Rupture of Membranes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 18 Dec 2015 (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.
To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.
Detailed description
The micronutrient vitamin C is an effective water soluble antioxidant that scavenges several reactive oxygen species, thus reducing oxidative stress, It also acts as an enzymatic cofactor to the enzymes lysyl hydroxylase and prolyl hydroxylase, which is required for synthesis of hydroxyproline and hydroxylysine, Collagen requires hydroxyproline bridges across the triple helix to provide stability to it, Ascorbic acid also causes down regulation of the metalloproteinase-2 and biosynthesis of collagen where it is required for the formation of triple helical structure of collagen. Thus, ascorbic acid participates in the equilibrium between synthesis and degradation of collagen and this may be critical in reducing the occurrence of preterm PROM.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Study group included 20 pregnant women with PPROM and fulfilled the inclusion and exclusion criteria. |
| control group | – | –Control group also included 20 pregnant women without PPROM following every recorded case of PPROM and matched for gestational age. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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 starting from January 2016. This study will include 40 pregnant women between 28-37 weeks were recruited.
Key inclusion criteria (3 listed)
- Singleton pregnancies
- Gestational age between 28-37 weeks
- Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal
Key exclusion criteria (6 listed)
- Patients with multiple pregnancies
- Smoker
- Polyhydramnios
- Maternal diseases such as: anemia, diabetes, UTI, RTI and vaginal infection
- History of PPROM in previous pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relation between serum vitamin C concentration and PPROM
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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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.
Sherif M Habib, MD study director
Professor of Obstetric and Gynecology
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Premature Rupture of Membranes, run by Ain Shams Maternity Hospital.
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 3 inclusion and 6 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 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Hu Mostafa, MD (01003993165 ext. 02, magicmostwanted@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation between serum vitamin C concentration and PPROM (time frame: 6 months). 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 18 Dec 2015.