NCT05134688

Brief Summary

To assess the outcome of using magnesium sulphate on fetus and women with preterm premature rupture of membranes

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
2.7 years until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

November 15, 2021

Last Update Submit

July 18, 2024

Conditions

Premature Rupture of Membrane

Keywords

Magnesium sulphate

Outcome Measures

Primary Outcomes (1)

  • Latency period after rupture of membranes

    Measure letancy period between prelabour rupture of membranes and delivery during using magnesium sulphate as a tocolytic and without using magnesium sulphate

    Baseline

Study Arms (2)

Grup 1

Group receive magnesium sulphate IV(4gm loading dose over 20 minutes followed by 1gm /hour for 6 hours

Drug: Magnesium sulfate

Group 2

Receive no further treatment than conservative mangement( antibiotics and steroids)

Interventions

Magnesium sulfateDRUG

Tocolytic to stop preterm labor

Grup 1

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective cohort study

You may qualify if:

  • pregnant women with gastational age between 28 weeks and 36 weeks and 6 days who are diagnosed with preterm prelabour rupture of membranes

You may not qualify if:

  • clinical suspicion of chorioamnionitis
  • Patients refusal to participate in clinical research.
  • significant vaginal bleeding
  • previous tocolysis use after rupture of membranes
  • nonreassuring fetal heart tracing
  • fetal anomalies
  • significant maternal medical complications, and maternal or fetal indication for delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Parry S, Strauss JF 3rd. Premature rupture of the fetal membranes. N Engl J Med. 1998 Mar 5;338(10):663-70. doi: 10.1056/NEJM199803053381006. No abstract available.

    PMID: 9486996BACKGROUND

  • Kaltreider DF, Kohl S. Epidemiology of preterm delivery. Clin Obstet Gynecol. 1980 Mar;23(1):17-31. doi: 10.1097/00003081-198003000-00005.

    PMID: 6988128BACKGROUND

  • ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynecologists. Obstet Gynecol. 2007 Apr;109(4):1007-19. doi: 10.1097/01.AOG.0000263888.69178.1f.

    PMID: 17400872BACKGROUND

  • Crowther CA, Harding JE. Repeat doses of prenatal corticosteroids for women at risk of preterm birth for preventing neonatal respiratory disease. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003935. doi: 10.1002/14651858.CD003935.pub2.

    PMID: 17636741BACKGROUND

  • McNamara HC, Crowther CA, Brown J. Different treatment regimens of magnesium sulphate for tocolysis in women in preterm labour. Cochrane Database Syst Rev. 2015 Dec 14;2015(12):CD011200. doi: 10.1002/14651858.CD011200.pub2.

    PMID: 26662716BACKGROUND

  • Shatrov JG, Birch SCM, Lam LT, Quinlivan JA, McIntyre S, Mendz GL. Chorioamnionitis and cerebral palsy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):387-392. doi: 10.1097/AOG.0b013e3181e90046.

    PMID: 20664400BACKGROUND

  • Weiner CP, Renk K, Klugman M. The therapeutic efficacy and cost-effectiveness of aggressive tocolysis for premature labor associated with premature rupture of the membranes. Am J Obstet Gynecol. 1988 Jul;159(1):216-22. doi: 10.1016/0002-9378(88)90524-8.

    PMID: 3134815BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Central Study Contacts

Ahmed Fathi

CONTACT

01002058742Ahmedalfathi94@gmail.com

Diaa eldeen Abdelaal

CONTACT

01005212137Abdelaald@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmed Fathi Abdelraouf

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 26, 2021

Study Start

July 30, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07