The primary objectives of this study are 1) to assess the factors and considerations that play a role in the decision-making process of either multifetal pregnancy reduction or maintaining a multifetal pregnancy, and 2) to assess the emotional…
ID
Source
Brief title
Condition
- Other condition
- Postpartum and puerperal disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Health condition
Emotioneel welbevinden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
These include the results of the thematic analysis of the interviews, mainly
focusing on 1) the factors and considerations that play a role in the
decision-making process of multifetal pregnancy reduction, and 2) the emotional
aspects and consequences of the decision to or not to perform multifetal
pregnancy reduction, during pregnancy and thereafter
Secondary outcome
To assess:1) How parents look back at the decision of reducing or maintaining
their multifetal pregnancy, 2) If and how the decision affected the parents*
relationship, 3) The satisfaction with the information that was provided, prior
to the decision, 4) The satisfaction with the guidance during the
decision-making process and thereafter
Background summary
Multifetal pregnancies, especially triplets and higher-order multifetal
pregnancies, are associated with an increased risk of perinatal and maternal
morbidity and mortality. Therefore, all women with higher-order multifetal
pregnancies should be counselled for the possibility of multifetal pregnancy
reduction. In the decision-making process to or not to perform multifetal
pregnancy reduction the risk of the procedure (i.e. a small chance of
miscarriage) has to be balanced against the possible medical complications
associated with a multifetal pregnancy. In order to optimize the
decision-making process of reducing or maintaining a multifetal pregnancy it is
important for clinicians to understand parents* considerations and decisions
during this process, and also to provide parents accurate information on the
psychological health state shortly after multifetal pregnancy (reduction) as
well as in the years thereafter. Therefore, the aim of this study is to
increase knowledge on the decision-making process of reducing or maintaining a
multifetal pregnancy and to assess the emotional impact of this decision during
pregnancy and thereafter. This information can be used by
obstetrician-gynaecologists in the future to optimize information for and
guidance of parents with multifetal pregnancies, so they can make a
well-informed decision on reducing or maintaining their multifetal pregnancy.
Study objective
The primary objectives of this study are 1) to assess the factors and
considerations that play a role in the decision-making process of either
multifetal pregnancy reduction or maintaining a multifetal pregnancy, and 2) to
assess the emotional aspects and consequences of the decision, during pregnancy
and thereafter.
Study design
Qualitative cross-sectional study using semi-structured face-to-face in depth
interviews
Study burden and risks
Based on the NFU risk classification, we estimate the risk of participating in
this study *negligible*. The potential risk of psychological discomfort related
to this study is highlighted in the patient information form (PIF). If any of
these feelings occur during the study period the participant is asked to either
contact the research team or to (anonymously) contact the independent expert.
In case of any concerns the psychiatrist in our research team can be consulted
for advice. In any case, professional help can be offered. The general
practitioner then will be notified. We will pay extra attention on the
emotional well-being of women and biological fathers who experienced (severe)
pregnancy complications such as loss of their child or children or loss of the
entire pregnancy. We hope that participation in this study will offer the
possibility to improve processing of the participant*s emotions. All
participants will be contacted by telephone within two weeks after their
interview to evaluate how they look back on participating in this study. We use
this moment to assess for possible psychological distress and if participants
require any further professional care or follow-up.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Mothers: 1) A woman with a history of multifetal pregnancy reduction, from
triplet to twin or triplet to singleton from 1 year ago until 6 years ago, 2) A
woman with a history of an ongoing triplet pregnancy, counselled for multifetal
pregnancy reduction from 1 year ago until 6 years ago . Fathers: 1) A
biological father of a triplet pregnancy where counselling for multifetal
pregnancy reduction took place from 1 year ago until 6 years ago.
Exclusion criteria
1) Age < 18 years, 2) The procedure of multifetal pregnancy reduction was
performed because of a congenitally abnormal fetus, 3) The procedure of
multifetal pregnancy reduction was performed because of a serious maternal
medical indication, 4) The woman was not counselled for multifetal pregnancy
reduction, 5) The woman or biological father does not speak and understand the
Dutch language, 6) Objection about the use of data for research was made
previously.
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 | NL74482.029.20 |