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

Preterm Premature Rupture of Membranes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02635451
• Other study ID #: MHMostafa
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2015
• Last updated: December 17, 2015
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: December 2015
• Source: Ain Shams Maternity Hospital
• Contact: Mohamed Hu Mostafa, MD
• Phone: 01003993165
• Email: magicmostwanted[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membranes
• Rupture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relation between serum vitamin C concentration and PPROM		6 months	Yes