Primary outcome is to evaluate whether successful ECV is associated with maternal thyroid function and mood state in single pregnant women with breech position at end term.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Main study parameter is the difference in mean
FT4 (thyroid hormone) in women with successful ECV compared to those with no
successful outcome of ECV. Moreover the independent relation between maternal
mood state versus successful ECV will be assessed.
Secondary outcome
A secondary outcome is to evaluate whether neonatal thyroid parameters is
associated with ECV.
Background summary
Maternal hypothyroxinemia during gestation is associated with impaired motor
development of the offspring. Foetal movements is generally accepted to be
important to present the foetus at term in cephalic position. Breech position
is associated with increased foetal and maternal morbidity which means that low
risk interventions that can reduce breech position may reduce this increased
risk. External cephalic version (ECV) is a low risk intervention which - if
successful - reduces the risk of Caesarean Section up to 80%. Until now, ECV is
successfully performed in 40 - 50% of the cases.
Parity, type of breech presentation, localisation of the placenta and
birthweight are important determinants of succes.
So far no biochemical determinants are known.
Study objective
Primary outcome is to evaluate whether successful ECV is associated with
maternal thyroid function and mood state in single pregnant women with breech
position at end term.
Study design
Prospective observational study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: There is no burden and risk associated with
participation: women are only asked to participate into EBIS after they decided
to have ECV as part of routine good clinical practice. Assessment of blood
samples also do not include additional invasive research: all women already
have a vena-punction as a parameter of the safety protocol for routine ECV in
clinical practice. Neonatal thyroid parameters will be assessed in cord blood
after the dissection of the placenta from the umbilical cord.
Intervention (if applicable): No additional intervention is applicable except
for several questionnaires to assess maternal mood state.
Michelangelolaan 2
6523 EJ Eindhoven
Nederland
Michelangelolaan 2
6523 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
-Single pregnancy
-Gestation of 35 weeks or more
-Appropriate knowledge of the Dutch language
-Foetus in any of the 4 types of breech presentation:
• Frank breech presentation (highest incidence)
• Complete breech presentation (nonfrank breech presentation)
• Incomplete breech presentation
• Footling presentation
Exclusion criteria
• Indications for caesarean delivery irrespective of presentation (eg, placenta previa)
• Previous caesarean section
• Previous abruptio placenta
• Multiple pregnancy
• Ruptured membranes
• Nonreassuring fetal monitoring test results
• Hyperextended fetal head
• Significant fetal or uterine anomaly
• Use of thyroid medication
• Maternal autoimmune diseases such as insulin-dependent diabetes mellitus or rheumatoid arthritis
• Intra-uterine growth retardation
• Oligo or anhydramnion
• Hiv-positive women
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14584.060.06 |