Condition category
Pregnancy and Childbirth
Date applied
04/05/2020
Date assigned
11/05/2020
Last edited
11/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Since the number of women using modern methods of contraception is suboptimal, unintended pregnancies remain a persistent problem in the Republic of Moldova. However, the number of abortions in the Republic of Moldova decreased from 14,511 in 2013 to 10,830 in 2018. There are no data in the Republic of Moldova that state how many pregnancies that finalise with delivery are planned and how many of them were unintended. The aim of the study is to assess the level of knowledge, use and uptake of using family planning methods in women evaluated in the postpartum period.

Who can participate?
Women over 18 years who gave birth within the last 24-72 hours

What does the study involve?
The study involves a conversation with the investigator based on a survey that includes 58 questions about the medical history of the patient, questions about their knowledge about family planning methods, contraceptive methods used up to the present pregnancy, how the pregnancy occurred (planned or not), reasons for not using a contraceptive method if they did not plan a pregnancy and the prospect of using modern contraceptives after giving birth in future, after discharge from hospital.

What are the possible benefits and risks of participating?
There were no harms or risks for the participants of the study. No information that could identify the subject is collected. No laboratory investigations are done. The medical chart with personal and private data is not used. All information is provided on a voluntary basis. As a general benefit the conversation with the participant during the survey process aims to improve their knowledge of family planning methods and also helps women think about the possibility of using family planning methods in future, if they did not do so before, it raises some questions about their awareness, maybe points out some gaps that they could work on in the future.

Where is the study run from?
Nicolae Testemițanu State University of Medicine and Pharmacy (Moldova)

When is the study starting and how long is it expected to run for?
February 2019 to December 2019

Who is funding the study?
Nicolae Testemițanu State University of Medicine and Pharmacy (Moldova)

Who is the main contact?
Dr Irina Sagaidac
irina.sagaidac@usmf.md

Trial website

Contact information

Type

Public

Primary contact

Mrs Cemortan Maria

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Nicolae Testemitanu State University of Medicine and Pharmacy
Chisinau
MD 2004
Moldova
+373 (0)69672425
maria.cemortan@usmf.md

Type

Scientific

Additional contact

Dr Irina Sagaidac

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Nicolae Testemitanu State University of Medicine and Pharmacy
Chisinau
MD 2004
Moldova
+373 (0)69340259
irina.sagaidac@usmf.md

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Contraception use among women in the Republic of Moldova planned vs unplanned pregnancies

Acronym

Study hypothesis

This study aimed to assess the level of knowledge, use and uptake of using family planning methods in women evaluated in the postpartum period.

Ethics approval

Approved 11/02/2019, Ethics Review Committee of Hospital no.1, Chisinau (Institutia Medico-Sanitara Publica, Spitalul Clinic Municipal Nr.1, MD 2001, mun. Chisinau str. Melestiu, 20, Moldova; +373 (0)270479; scm1@ms.md): ref: not applicable

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Contraception methods

Intervention

Women in the postpartum period were evaluated. The cases were divided into two groups - group 1, in which the pregnancy was unplanned but was accepted psychologically and women gave birth, and group 2 which covered the women who consciously did not use contraception because they were planning a pregnancy.

Women answered a list of 58 questions about the contraception methods they know and used before this pregnancy, whether the pregnancy was intended or not, and perspective on using modern contraception methods after the current birth.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Number of planned and unplanned pregnancies
2. Contraception methods used
Both assessed using a questionnaire at a single timepoint

Secondary outcome measures

1. Knowledge about family planning methods
2. Attitudes to family planning methods
3. Perspective on using contraceptive methods postpartum
4. Perspective on an unwanted pregnancy in the future
All assessed using a questionnaire at a single timepoint

Overall trial start date

01/02/2019

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women in the postpartum period of 24-72 hours, who gave informed consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

600

Total final enrolment

600

Participant exclusion criteria

Cases where pregnancy occurred after a period of infertility

Recruitment start date

01/03/2019

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Moldova

Trial participating centre

Hospital no. 1
str. Melestiu, 20
Chisinau
MD2001
Moldova

Sponsor information

Organisation

Nicolae Testemițanu State University of Medicine and Pharmacy

Sponsor details

Bd. Stefan cel Mare si Sfant 165
Chisinau
MD 2004
Moldova
+373 (0)22205701
contact@usmf.md

Sponsor type

University/education

Website

http://usmf.md/en/

Funders

Funder type

University/education

Funder name

Nicolae Testemițanu State University of Medicine and Pharmacy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the study are planned to be published in the BMC journal Reproductive Health.

IPD sharing statement
The datasets used and/or analyzed during the current study are available upon request from Maria Cemortan (maria.cemortan@usmf.md). Data files with fully anonymized data, both raw data and subscales for each measure along with some basic demographic data will be available from January 2021 for at least 5 years (indefinitely if it is possible to formally archive). Data will be made available to researchers who have ethical approval to conduct studies that are in line with the original aims of the study. Consent from participants has been given for this, and none of the data will be identifiable.

Intention to publish date

01/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/05/2020: Trial's existence confirmed by Ethics Review Committee of Hospital no.1, Chisinau.