Maternal and fetal haemodynamic response to Nifedipine tocolysis in normotensive pregnant women. - CORCA I

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000467-23-NL

Enrollment

Registered

2007-02-15

Start date

2007-08-23

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A more detailed investigation of the haemodynamic effect on the mother and fetus of Nifedipine tocolysis . Tocolysis will be used to facilitate external cephalic version for breech presentation at term. MedDRA version: 9.1 Level: LLT Classification code 10006356 Term: Breech presentation MedDRA version: 9.1 Level: LLT Classification code 10048773 Term: Tocolysis MedDRA version: 9.1 Level: LLT Classification code 10013596 Term: Doppler ultrasound MedDRA version: 9.1 Level: LLT Classification

Interventions

Trade Name: Nifedipine 10 PCH Product Name: Nifedipine 10 PCH Pharmaceutical Form: Capsule* INN or Proposed INN: NIFEDIPINE CAS Number: 21829254 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: normotensive term singleton pregnancy fetus in breech presentation opted for external cephalic version tocolysis with Nifedipine Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: contraindication for external cephalic version contraindication for vaginal delivery contraindication for nifedipine cardiac disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the haemodynamic effects of Nifedipine tocolysis in normotensive pregnant women and their fetus by maternal echocardiography and fetal doppler ultrasound.;Secondary Objective: ;Primary end point(s): blood pressure and echocardiographic parameters of maternal haemodynamics (systolic function, diastolic function) doppler indices of uteroplacental and fetal haemodynamics	—

Measure

Time frame

Main Objective: To investigate the haemodynamic effects of Nifedipine tocolysis in normotensive pregnant women and their fetus by maternal echocardiography and fetal doppler ultrasound.;Secondary Objective: ;Primary end point(s): blood pressure and echocardiographic parameters of maternal haemodynamics (systolic function, diastolic function) doppler indices of uteroplacental and fetal haemodynamics

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026