EBIS: The Eindhoven Breech Intervention Study

Catharina Hospital

Status: Completed

Conditions: External Cephalic Version; Thyroid Hormones; Congenital Hip Dysplasia; Breech Presentation; Stress, Psychological

Study type: Observational

Funder types: Other

Identifiers

NCT00516555

M06/1130

ABR Number 14584

Details and patient eligibility

About

The purpose of this study is to evaluate whether successful external cephalic version is associated with maternal thyroid function and mood state in pregnant women with breech presentation at term.

The relationship between successful external cephalic version and neonatal thyroid function will also be investigated.

A possible beneficial effect of successful external cephalic version on the development of congenital hip dysplasia will be evaluated.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single pregnancy
• Gestation of 35 weeks or more
• Appropriate knowledge of the Dutch language
• Fetus in any of the 4 types of breech presentation: frank breech, complete breech, incomplete breech or footling presentation

Exclusion criteria

• Previous caesarean section
• Indication for caesarean delivery irrespective of presentation
• Previous abruptio placenta
• Multiple pregnancy
• Ruptured membranes
• Non-reassuring fetal monitoring tests results
• Hyperextended fetal head
• Significant uterine or fetal anomaly
• Use of thyroid medication
• Maternal autoimmune disease (such as insulin-dependant diabetes mellitus)
• Intra-uterine growth retardation
• Oligohydramnios
• HIV-positive women

Trial design

250 participants in 1 patient group

A, 07, 001

Description:

Pregnant women at term with a baby in breech presentation who will have an external cephalic version.