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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635451
Recruitment Status : Unknown
Verified December 2015 by Mohamed Hussein Mostafa, Ain Shams Maternity Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed Hussein Mostafa, Ain Shams Maternity Hospital

Brief Summary:
To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.

Condition or disease
Preterm Premature Rupture of Membranes

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes
Study Start Date : January 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears Vitamin C

Group/Cohort
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.



Primary Outcome Measures :
  1. relation between serum vitamin C concentration and PPROM [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635451


Contacts
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Contact: Mohamed Hu Mostafa, MD 01003993165 ext 02 magicmostwanted@yahoo.com
Contact: Mohamed Hu Mostafa, MD 01003993912 ext 02 magic2mostwanted@yahoo.com

Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Study Director: Sherif M Habib, MD Professor of Obstetric and Gynecology
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Responsible Party: Mohamed Hussein Mostafa, Assistant Professor of Obstetric and Gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02635451    
Other Study ID Numbers: MHMostafa
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Keywords provided by Mohamed Hussein Mostafa, Ain Shams Maternity Hospital:
vitamin c
Preterm Premature Rupture of Membranes
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries