Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-01 @ 9:28 AM
Study NCT ID:
NCT03989869
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2019-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Early Medical Abortion
Sponsor:
NHS Lothian
Organization:
Study Overview
Official Title:
Very Early Medical Abortion - a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VEMASCOT
Brief Summary:
The research question begin addressed by this study is "Is Very Early Medical Abortion (VEMA - before a pregnancy is visible on ultrasound scan) as effective as medical abortion when performed later and an intrauterine pregnancy can be visualised with ultrasound?".
This is important to patients and public, because delays to abortion care can cause mental distress, and pain and bleeding are worse at later gestations.
The study is examining whether earlier or delayed administration of abortion medications affects the efficacy and side effects of the medical abortion process, in women with very early pregnancies.
Any women who had a positive pregnancy test, requesting abortion, but did not have a visible pregnancy on ultrasound scan could take part in the study. Women with signs, symptoms or ultrasound findings suggesting ectopic pregnancy would not be included.
This study will be conducted at a community sexual and reproductive health centre that provides abortion care.
The participants will be involved in the study for a maximum period of 4 weeks. They will be randomly allocated to either immediate abortion care or delayed abortion care. In each arm of the study they will receive clinical care that they would otherwise routinely receive. In addition to this, they will receive a telephone call follow up with a short questionnaire to complete over the phone.
This study is being conducted in Scotland but the results will be combined with findings from similar research groups across Europe as part of a consortium of researchers. This consortium is coordinated by the Karolinska Institutet in Sweden under the EuDRACT ID: 2018-003675-35
This is important to patients and public, because delays to abortion care can cause mental distress, and pain and bleeding are worse at later gestations.
The study is examining whether earlier or delayed administration of abortion medications affects the efficacy and side effects of the medical abortion process, in women with very early pregnancies.
Any women who had a positive pregnancy test, requesting abortion, but did not have a visible pregnancy on ultrasound scan could take part in the study. Women with signs, symptoms or ultrasound findings suggesting ectopic pregnancy would not be included.
This study will be conducted at a community sexual and reproductive health centre that provides abortion care.
The participants will be involved in the study for a maximum period of 4 weeks. They will be randomly allocated to either immediate abortion care or delayed abortion care. In each arm of the study they will receive clinical care that they would otherwise routinely receive. In addition to this, they will receive a telephone call follow up with a short questionnaire to complete over the phone.
This study is being conducted in Scotland but the results will be combined with findings from similar research groups across Europe as part of a consortium of researchers. This consortium is coordinated by the Karolinska Institutet in Sweden under the EuDRACT ID: 2018-003675-35
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 257387 | OTHER | IRAS (NHS Ethics) | View |