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Placenta Previa BleedingPhase 2NCT04599868

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

A Phase 2 study testing Magnesium sulfate in people with Placenta Previa Bleeding, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 16 to 45 years, women only
Conditions the study is for
Placenta Previa Bleeding
What is being tested?
Magnesium sulfate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteEgypt
Study dates
1 Dec 2020to 20 Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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 .

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University

    Asyut, 71111

Other trials in Egypt

About this study

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

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 .

Read the 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

Being tested
Magnesium sulfate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium sulfateDrug

    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.

Study groups in NCT04599868
Study groupRoleWhat they receive
Low dose of magnesium sulfate groupActive comparatorpatients 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
Receives: Drug: Magnesium sulfate
High dose of magnesium sulfate groupActive comparatorpatients 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
Receives: Drug: Magnesium sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 48 hour

Secondary outcomes (6)

  1. Gestational age at delivery

    Measured: at time of delivery

  2. birth weight

    Measured: at time of delivery

  3. number of full term babies

    Measured: at time of delivery

  4. fetal and Neonatal death .

    Measured: at time of delivery

  5. Apgar score at five minutes .

    Measured: 5 minutes

  6. Neonatal intensive care unit admission & duration of admission

    Measured: at time of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start1 Dec 2020
  3. Primary completion20 Aug 2022
  4. Study completion20 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04599868
Sponsor's protocol ID
Mgso4 for PTL in pp
Status last verified
Sep 2022
First submitted
5 Oct 2020
Last updated
14 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30591076

  • 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.

    PubMed 22071057

  • 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.

    PubMed 19650556

  • 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.

    PubMed 27399261

  • 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.

    PubMed 28033694

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

  • 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.

    PubMed 14871511

  • 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

  • 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.

    PubMed 21773032

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magnesium sulfate in people with Placenta Previa Bleeding, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 48 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04599868, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.

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