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

High Versus Low Dose of Magnesium Sulfate as Initial Tocolytic Agent for Preterm Labour in Symptomatic Placenta Previa: A Randomized Controlled Study

Sponsors

Lead Sponsor: Assiut University

Source Assiut University
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 .

Detailed Description

Placenta previa is implantation of placenta on or near internal os .It is classified into major degree when lower edge of placenta lies within 2 cm from internal os , and minor degree if lower edge of placenta at lower uterine segment but more than 2 cm from internal os . There are many risk factors for developing placenta previa including multi parity , multiple pregnancy , increased maternal age (>35y ) , previous uterine surgery , history of placenta previa (4-8%) . A significant degree of uterine contractility has been observed with symptomatic placenta previa. It is directly associated with vaginal bleeding. However, a large percentage of women who have placenta previa associated with haemorrhage will experience subclinical uterine contractions before the onset of overt vaginal bleeding. Therefore, the use of tocolytic agents in management of placenta previa seems reasonable . Magnesium sulfate alters calcium up take, binding and distribution in smooth muscles of the uterus, so reduces the frequency of cell depolarization and inhibits myometrial contraction . In addition to its tocolytic action magnesium sulfate also provide neuroprotection to preterm infant . . At women Health Hospital, Assiut University, Egypt our policy is using magnesium sulfate as first line for tocolysis for placenta previa patients with preterm uterine contractions. By giving a loading dose of 4 g on 150 ml saline intravenous infusion over 20 minutes, and a maintenance dose of 6g/6h on 500 ml saline slow intra venous infusion

Overall Status Not yet recruiting
Start Date December 1, 2020
Completion Date November 1, 2022
Primary Completion Date October 1, 2022
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
1) Evaluate efficacy ( postponing delivery for 48h - till administration of dexamethason ) of different regimens 0f MgSO4 in patients with pp in PTL . 2) Different regimens of MGSO4 and changes in cervical length 48 hour
Secondary Outcome
Measure Time Frame
GA 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
Neonatal ICU admission & duration of admition at time of delivery
Enrollment 130
Condition
Intervention

Intervention Type: Drug

Intervention Name: magnesium sulfate

Description: 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. RH 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 ICU admission and duration of admission and neonatal calcium level at time of delivery will be also assessed.

Eligibility

Criteria:

Inclusion Criteria: 1. Singleton pregnancy. 2. Gestational age between 28 weeks to 37 weeks. 3. Patients presented to the hospital with per vaginal bleeding and in whom a clinical diagnosis of placenta previa is confirmed by trans vaginal ultrasound. 4. Placenta previa with preterm uterine contractions (< 3 contractions in 10 minutes) 5. Ability to provide informed consent. Exclusion Criteria: 1. Placental abruption . 2. Women with placenta previa and severe attack of bleeding need immediate termination 3. Clinical criteria of intra uterine infection. 4. IUGR. 5. Fetal anomalies. 6. Fetal distress. 7. IUFD. 8. PROM 9. High order multiple pregnancies. 10. Treatment with any tocolytic agent before maternal transport. 11. Inability or refusal to provide informed consent. 12. Women with any contraindication for use of magnesium sulfate as patients with renal failure. 13. Patients with bleeding disorder or on anticoagulant therapy .

Gender: Female

Gender Based: Yes

Gender Description: only females

Minimum Age: 16 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Contact

Last Name: Doaa Mostafa Mahmoud, resident doctor

Phone: 01061699727

Email: [email protected]

Verification Date

November 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: Doaa M. Mostafa

Investigator Title: Resident of obstetrics &Gynecology

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: low dose of magnesium sulfat

Type: Active Comparator

Description: 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 ( low dose group

Label: High dose of magnesium sulfat

Type: Active Comparator

Description: 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 ( high dose group )

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov