Family PlanningNCT03135288
Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives
A study testing Cell-phone in people with Family Planning, run by Assiut University at 1 site in Egypt.
Trial summary
Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Family Planning
- What is being tested?
- Cell-phone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who deliver a live birth at greater than 28 week's gestation.
- Women desire birth spacing for more than one year
- Women who were holding and /or one of her family hold a cell-phone and accept to receive messages and phone calls to remind her with her contraceptive program
Who cannot join
- Women who refuse to participate in the study.
- Women aren't able to respond to the questionnaire due to their health status.
- Anticipation of difficulty of subsequent communication with the women
- Women with contraindications of using long acting reversible contraception ( contraindicated if intrauterine device or implant use)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.
- Conditions
- Family Planning
- Being tested
- Cell-phone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-phoneDevice
a reminder of their postpartum family planning visit 5 weeks after the delivery (one week before the scheduled visit) and a phone call 48 hours before the scheduled visit. They will also receive two follow-up phone calls to answer any questions and to remind them with the follow-up visits after insertion. Woman will be given a referral card to the outpatients' family planning clinic denoting her study group and serial number and with a specific date for postpartum family planning visits.
| Study group | Role | What they receive |
|---|---|---|
| Cell-phone assisted | Experimental | will be advised that they are going to receive a reminder of their postpartum family planning visit 5 weeks after the delivery (one week before the scheduled visit) and a phone call 48 hours before the scheduled visit. They will also receive two follow-up phone calls to answer any questions and to remind them with the follow-up visits after insertion. Woman will be given a referral card to the outpatients' family planning clinic denoting her study group and serial number and with a specific date for postpartum family planning visits. They will be also provided with a cell phone number working 7 days a week to answer any query or questions regarding her family planning program. Receives: Device: Cell-phone |
| control group | No intervention | will receive the same above adequate counseling with referral card but without any phone assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of Long acting reversible contraception method
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Jul 2017
- Primary completion15 Mar 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family PlanningStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135288
- Sponsor's protocol ID
- CP-LARC
- Status last verified
- Jul 2019
- First submitted
- 27 Apr 2017
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
PubMed 32813276Shaaban OM, Saber T, Youness E, Farouk M, Abbas AM. Effect of a mobile phone-assisted postpartum family planning service on the use of long-acting reversible contraception: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Aug;25(4):264-268. doi: 10.1080/13625187.2020.1764528. Epub 2020 May 21.
PubMed 32436800
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03135288
- Acronym / sponsor ID
- CP-LARC
- Conditions
- Family Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell-phone assisted | Experimental | Device: Cell-phonewill be advised that they are going to receive a reminder of their postpartum family planning visit 5 weeks after the delivery (one week before the scheduled visit) and a phone call 48 hours before the scheduled visit. They will also receive two follow-up phone calls to answer any questions and to remind them with the follow-up visits after insertion. Woman will be given a referral card to the outpatients' family planning clinic denoting her study group and serial number and with a specific date for postpartum family planning visits. They will be also provided with a cell phone number working 7 days a week to answer any query or questions regarding her family planning program. |
| control group | No intervention | –will receive the same above adequate counseling with referral card but without any phone assistance |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women who deliver a live birth at greater than 28 week's gestation.
- Women desire birth spacing for more than one year
- Women who were holding and /or one of her family hold a cell-phone and accept to receive messages and phone calls to remind her with her contraceptive program
Key exclusion criteria (4 listed)
- Women who refuse to participate in the study.
- Women aren't able to respond to the questionnaire due to their health status.
- Anticipation of difficulty of subsequent communication with the women
- Women with contraindications of using long acting reversible contraception ( contraindicated if intrauterine device or implant use)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell-phonea reminder of their postpartum family planning visit 5 weeks after the delivery (one week before the scheduled visit) and a phone call 48 hours before the scheduled visit. They will also receive two follow-up phone calls to answer any questions and to remind them with the follow-up visits after insertion. Woman will be given a referral card to the outpatients' family planning clinic denoting her study group and serial number and with a specific date for postpartum family planning visits. | Device | Cell-phone assisted |
Primary outcome
Initiation of Long acting reversible contraception method
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 32813276Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
- Derived from this study: PubMed 32436800Shaaban OM, Saber T, Youness E, Farouk M, Abbas AM. Effect of a mobile phone-assisted postpartum family planning service on the use of long-acting reversible contraception: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Aug;25(4):264-268. doi: 10.1080/13625187.2020.1764528. Epub 2020 May 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell-phone in people with Family Planning, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of Long acting reversible contraception method (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135288, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.