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
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