High Versus Low Dose of Magnesium Sulfate as Initial Tocolytic Agent for Preterm Labour in Symptomatic Placenta Previa.

NCT04599868 | Completed Phase 2

• 1 other identifier: Mgso4 for PTL in pp
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of alternative magnesium sulfate regimens when used as single agent tocolytic therapy for prevention of preterm labour in patients with symptomatic placenta previa and subsequent changes in the cervical length .

Conditions

Placenta Previa Bleeding

Outcome Measures

Primary Outcomes (1)

• Evaluate efficacy (postponing delivery for 48h - till administration of dexamethasone ) of different regimens 0f MgSO4 in patients with pp in preterm . 2) Different regimens of MGSO4 and changes in cervical length

  comparing efficacy of low vs high dose of MgSO4 to postpone preterm delivery in patients with symptomatic pp and subsequent changes in cervical length

  48 hour

Secondary Outcomes (6)

• Gestational age at delivery

  at time of delivery

• birth weight

  at time of delivery

• number of full term babies

  at time of delivery

• fetal and Neonatal death .

  at time of delivery

• Apgar score at five minutes .

  5 minutes

Study Arms (2)

Low dose of magnesium sulfate group

ACTIVE COMPARATOR

patients will receive 4 g intravenous loading dose of magnesium sulfate on 150 ml saline over 20 minute period. Patients then will receive maintenance therapy with magnesium sulfate 1g / h

Drug: Magnesium sulfate

High dose of magnesium sulfate group

ACTIVE COMPARATOR

patients will receive 4 g intravenous loading dose of magnesium sulfate on 150 ml saline over 20 minute period. Patients then will receive maintenance therapy with magnesium sulfate 2g/h

Drug: Magnesium sulfate

Interventions

Magnesium sulfate DRUG

Patients will be assessed hourly for pulse and blood pressure, contraction frequency, vaginal bleeding. With strict monitoring for symptoms of magnesium sulfate toxicity. All patients will receive dexamethasone to enhance fetal lung maturity. Rhesus factor status will be determined for all patients, . Hb level will be measured and anemic patients will receive correction by blood transfusion Cervical length will be measured after 24 h\& 48 h from administration of magnesium sulfate in both groups Maternal serum magnesium will be measured at admission and after 4 hours ,12 hours and 24 hours after administration of magnesium sulfate Patients of both groups will be assessed for their neonatal outcomes include deaths and gestational age at delivery, fetal birth weight. Apgar score at five minutes, neonatal intensive care unit admission and duration of admission and neonatal calcium level at time of delivery will be also assessed.

High dose of magnesium sulfate group; Low dose of magnesium sulfate group

Eligibility Criteria

• Age: 16 Years - 45 Years
• Gender Eligibility Details: only females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Singleton pregnancy.
• Gestational age between 28 weeks to 37 weeks.
• Patients presented to the hospital with per vaginal bleeding and in whom a clinical diagnosis of placenta previa is confirmed by trans vaginal ultrasound.
• Placenta previa with preterm uterine contractions (\< 3 contractions in 10 minutes)
• Ability to provide informed consent.

You may not qualify if:

• Placental abruption .
• Women with placenta previa and severe attack of bleeding need immediate termination
• Clinical criteria of intra uterine infection.
• intrauterine growth restriction .
• Fetal anomalies.
• Fetal distress.
• intrauterine fetal death.
• Preterm rupture of membrane
• High order multiple pregnancies.
• Treatment with any tocolytic agent before maternal transport.
• Inability or refusal to provide informed consent.
• Women with any contraindication for use of magnesium sulfate as patients with renal failure.
• Patients with bleeding disorder or on anticoagulant therapy .

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (9)

• Morfaw F, Fundoh M, Bartoszko J, Mbuagbaw L, Thabane L. Using tocolysis in pregnant women with symptomatic placenta praevia does not significantly improve prenatal, perinatal, neonatal and maternal outcomes: a systematic review and meta-analysis. Syst Rev. 2018 Dec 27;7(1):249. doi: 10.1186/s13643-018-0923-2.

  PMID: 30591076 BACKGROUND

• Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.

  PMID: 22071057 BACKGROUND

• Milosevic J, Lilic V, Tasic M, Radovic-Janosevic D, Stefanovic M, Antic V. [Placental complications after a previous cesarean section]. Med Pregl. 2009 May-Jun;62(5-6):212-6. doi: 10.2298/mpns0906212m. Serbian.

  PMID: 19650556 BACKGROUND

• Wennberg AL, Opdahl S, Bergh C, Aaris Henningsen AK, Gissler M, Romundstad LB, Pinborg A, Tiitinen A, Skjaerven R, Wennerholm UB. Effect of maternal age on maternal and neonatal outcomes after assisted reproductive technology. Fertil Steril. 2016 Oct;106(5):1142-1149.e14. doi: 10.1016/j.fertnstert.2016.06.021. Epub 2016 Jul 9.

  PMID: 27399261 BACKGROUND

• Saleh Gargari S, Seify Z, Haghighi L, Khoshnood Shariati M, Mirzamoradi M. Risk Factors and Consequent Outcomes of Placenta Previa: Report From a Referral Center. Acta Med Iran. 2016 Nov;54(11):713-717.

  PMID: 28033694 BACKGROUND

• ) Almnabri, A.A., et al., Management of Placenta Previa During Pregnancy. The Egyptian Journal of Hospital Medicine, 2017. 68(3): p. 1549-1553

  BACKGROUND

• Sharma A, Suri V, Gupta I. Tocolytic therapy in conservative management of symptomatic placenta previa. Int J Gynaecol Obstet. 2004 Feb;84(2):109-13. doi: 10.1016/S0020-7292(03)00198-X.

  PMID: 14871511 BACKGROUND

• 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: 26662716 BACKGROUND

• Kawagoe Y, Sameshima H, Ikenoue T, Yasuhi I, Kawarabayashi T. Magnesium sulfate as a second-line tocolytic agent for preterm labor: a randomized controlled trial in Kyushu Island. J Pregnancy. 2011;2011:965060. doi: 10.1155/2011/965060. Epub 2011 Jun 16.

  PMID: 21773032 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of obstetrics &Gynecology

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 23, 2020
• Study Start: December 1, 2020
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)