ClinicalTrials.gg
Not yet recruitingNCT05134688Updated Jul 22, 2024

Magnesium Sulphate in Premature Rupture of Membranes

An observational study in Premature Rupture of Membrane, sponsored by Assiut University. Not yet recruiting. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
124
Sex
Female
01

Study summary

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

Read the detailed description

Preterm premature rupture of membranes (PPROM) is defined as rupture of the chorioamniotic membranes before the onset of labor prior to 37 weeks of gestation. Approximately 1% to 5% of pregnancies are complicated by PPROM . PPROM contributes to perinatal morbidity and mortality, secondary to premature birth, and maternal morbidity. Overall, PPROM accounts for about one-third of all preterm births . In order to reduce the effects of prematurity, early PPROM (24 to 33 weeks) is best served with conservative management in the absence of labor, infection, or fetal distress . The conservative management of PPROM consists of the use of antibiotic treatment and antenatal steroid to enhance fetal lung maturity . With or without the presence of labor, it is unclear whether tocolysis of women with PPROM would be efficacious in reducing the consequences of prematurity .The use of tocolytics in women with PPROM is still controversial. Many physicians use tocolytic therapy as a prophylactic measure and others initiate tocolysis only with the onset of contractions. There is also a variety of options for tocolysis: betamimetics, calcium channel blockers, cyclo-oxygenase (COX) inhibitors, oxytocin receptor antagonists and magnesium sulphate . As betamimetis is not available and isn't used in our country and magnesium sulphate is available magnesium sulphate is used widly. The loading dose of magnesium sulphate is IV 4 gm over 20 minutes followed by 1gm/hour for 6 hours The potential benefit from increased latency due to tocolysis must be weighed against the potential harm in increased maternal and perinatal infection, the latter of which can possibly lead to long-term sequelae for the child, including cerebral palsy

02

Conditions studied

  • Premature Rupture of Membrane

Keywords

  • Magnesium sulphate
03

In context

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

This study's planned enrollment of 124 is close to the median of 122 across 36 observational studies indexed under Fetal Membranes, Premature Rupture.

Browse Fetal Membranes, Premature Rupture studies →

Lead sponsor

Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Prospective cohort study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
124 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 9486996 ↗
  • Kaltreider DF, Kohl S. Epidemiology of preterm delivery. Clin Obstet Gynecol. 1980 Mar;23(1):17-31. doi: 10.1097/00003081-198003000-00005. PubMed 6988128 ↗
  • 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. PubMed 17400872 ↗
  • 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. PubMed 17636741 ↗
  • 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. PubMed 26662716 ↗
  • 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. PubMed 20664400 ↗
  • 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. Erratum In: Am J Obstet Gynecol 1991 Sep;165(3):785. PubMed 3134815 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2024; primary completion for Sep 2024, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2021
First posted
Nov 26, 2021
StartEst.
Jul 30, 2024
Primary completionEst.
Sep 1, 2024
CompletionEst.
Dec 1, 2024
Last update
Jul 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05134688
Lead sponsor
Assiut University
Responsible party
Ahmed Fathi Abdelraouf (Ahmed Fathi Abdelraouf, Assiut University) — Principal investigator
First posted
Nov 26, 2021
Start date
Jul 30, 2024 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jul 22, 2024

Study contacts

Ahmed Fathi
Contact
Ahmedalfathi94@gmail.com
01002058742
Diaa eldeen Abdelaal
Contact
Abdelaald@yahoo.com
01005212137

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion