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The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes

NCT ID: NCT02635451

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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

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Preterm Premature Rupture of Membranes

Keywords

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vitamin c Preterm Premature Rupture of Membranes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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study group

Study group included 20 pregnant women with PPROM and fulfilled the inclusion and exclusion criteria.

No interventions assigned to this group

control group

Control group also included 20 pregnant women without PPROM following every recorded case of PPROM and matched for gestational age.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hussein Mostafa

Assistant Professor of Obstetric and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherif M Habib, MD

Role: STUDY_DIRECTOR

Professor of Obstetric and Gynecology

Central Contacts

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Mohamed Hu Mostafa, MD

Role: CONTACT

Phone: 01003993165

Email: [email protected]

Mohamed Hu Mostafa, MD

Role: CONTACT

Phone: 01003993912

Email: [email protected]

Other Identifiers

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MHMostafa

Identifier Type: -

Identifier Source: org_study_id