Magnesium Sulphate in Premature Rupture of Membranes

Premature Rupture of Membrane Clinical Trial

Official title:

Magnesium Sulphate for Tocolysis in Preterm Prelabour Rupture of Membranes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05134688
• Other study ID #: Magnesium sulphate in PPROM
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 30, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Ahmed Fathi
• Phone: 01002058742
• Email: Ahmedalfathi94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Magnesium sulfate
Tocolytic to stop preterm labor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2011;(6):CD003935. — View Citation

Kaltreider DF, Kohl S. Epidemiology of preterm delivery. Clin Obstet Gynecol. 1980 Mar;23(1):17-31. Review. — View Citation

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;(12):CD011200. doi: 10.1002/14651858.CD011200.pub2. Review. — View Citation

Parry S, Strauss JF 3rd. Premature rupture of the fetal membranes. N Engl J Med. 1998 Mar 5;338(10):663-70. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Am J Obstet Gynecol 1991 Sep;165(3):785. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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