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Completed

NCT Number: NCT04468568

In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

Myelomeningocele is a malformation with high incidence, and it consists in a neural tube defect. Fetal intrauterine surgery is an alternative for correction, and it improves the prognosis of the fetus, but has an increased risk of maternal complications and premature labor, as it can occur due to uterine stimulation. It is therefore essential that tocolysis is performed before, during and after surgery, and the most commonly used tocolytics are terbutaline and atosiban. Terbutaline has no specificity and may have several adverse effects such as maternal acidosis.

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Key information

Conditions

Myelomeningocele Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Meningomyelocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Pregnancy; Malformation Central Nervous System Terbutaline Adverse Reaction

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

About this study

The objective of the study was to evaluate maternal blood gas alterations among cases that used atosiban tocolytic agent and cases with terbutaline in in utero repair of myelomeningocele. It consists of a retrospective cohort study. It included 25 patients, who were divided into two groups, depending on which agent they received as main tocolytic agent during the intrauterine fetal myelomeningocele repair: terbutalineor atosiban. The primary outcome was maternal arterial pH at the end of surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women over 18 years
  • Single fetus pregnancy
  • Fetus with myelomeningocele
  • Gestational age from 19 to 26
  • Fetus with normal karyotype

Exclusion criteria

  • Multiple pregnancy
  • Fetal abnormality not related to myelomeningocele
  • Kyphosis greater than or equal to 30 degrees
  • Placenta previa
  • Maternal disease that increases the risk of pregnancy (insulin-dependent DM, hypertension poorly controlled)
  • History of incompetent cervix
  • Carrier of HIV, hepatitis B or hepatitis C
  • Maternal-fetal isoimmunization
  • Uterine Alteration
  • Obesity (IMC greater than 30)

Treatment and study plan

Atosiban

Drug

Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 21 hours.

Terbutaline

Drug

Terbutaline intravenous. Dose: 2.5 mg in 500 mL saline, infusion rate of 30 mL / hr (150 mcg / h) during the surgery and for 24 hours.

Primary outcomes

  1. Maternal arterial blood pH at the start of surgery

    Time frame: Right after intubation

    Arterial blood pH

  2. Maternal arterial blood pH at the end of surgery

    Time frame: Before extubation

    Arterial blood pH

  3. Maternal arterial blood pH at 120 minutes after surgery

    Time frame: Two hours after the end of surgery

    Arterial blood pH

Secondary outcomes

  1. Short-term fetal repercussions

    Time frame: In the end of the surgery, before extubation

    Fetal heart rate in the immediate postoperative period

  2. Long-term fetal repercussions

    Time frame: At the birth

    Gestational age at birth

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Assessment of Maternal Blood Gas Changes When Using Atosiban and Terbutaline as Tocolytic Agents, During in Utero Repair of Myelomeningocele

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Jul 13, 2020
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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