NCT03905395

Meditation and Mindfulness for Recurrent Pregnancy Loss

Status unknown NA Last updated 5 April 2019

What this trial tests

NA trial testing Meditation and mindfulness in Recurrent Pregnancy Loss in 64 participants. Status unknown.

Timeline

2 February 2019

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Henriette Svarre Nielsen, MD, DMSc
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	2 February 2019
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across Denmark

Drugs / interventions tested

• Meditation and mindfulness

Conditions studied

• Recurrent Pregnancy Loss — all drugs for Recurrent Pregnancy Loss →

Sponsor

Henriette Svarre Nielsen, MD, DMSc

Who can join

Adults 18 to 46, female only, with Recurrent Pregnancy Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines.

RPL affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.

42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8 % of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.

The study is a RCT including 62 patients - 31 in each arm. One arm will be taught in meditation and mindfulness three courses over a 7 week period. This group will also do meditation every day for 7 weeks. The other arm will have no intervention.

This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen. Furthermore this study will investigate if there's a marital benefit such as reinforcement in their relationsship from practicing meditation and mindfulness.

There is no previous study that has investigated meditation and mindfulness for RPL.

This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.