An mHealth Trial to Promote the Use of Postpartum Contraception (PPFP)
1. august 2018 opdateret af: Junaid-ur-Rehman Siddiqui
An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling.
Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies.
This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study will be a three-arm, 10-month, multicentre, parallel-group, randomized controlled trial which will be conducted at 15 Suraj social franchise(SF) health facilities in Punjab province of Pakistan.
Pregnant women aged 15-44 years who are in their first or second trimester and have a mobile phone for their own use will be eligible to participate in this study.
The participants will be randomly allocated to one of three study arms: a) voice and text messages; b) interactive telephone-based counselling; or c) control arm (no additional phone-based support).
The intervention counselling module will be developed based on the Integrated Behaviour Model which was recently adapted, and tested for the family planning context in Pakistan.
It will broadly cover birth-preparedness, birth spacing and contraception, and postnatal care.
The phone-based intervention aims to improve women's ability to use contraception by providing them with information about a range of methods, access to family planning methods through outlets such as Suraj SF providers, connecting them with MSS field health educators to help them reach the centres, motivation by re-enforcing the benefits of contraceptive use on women's quality of life, and dispelling myths and misconceptions about modern contraceptive methods.
Risk differences will be used as the measure of effect of the intervention on the outcomes.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
970
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Punjab
-
Hafizabad, Punjab, Pakistan
- Suraj Social Franchise
-
Jhang, Punjab, Pakistan
- Suraj Social Franchise
-
Kasur, Punjab, Pakistan
- Suraj Social Franchise
-
Toba Tek Singh, Punjab, Pakistan
- Suraj Social Franchise
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 44 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Married
- Pregnant women with gestational age up to 20 weeks
- 15-44 years old throughout duration of study
- Literate
- Access to a cellphone
- Living in the study's catchment area
Exclusion Criteria:
- Not up to 20 weeks pregnant
- Not between 15-44 years old for the study duration
- Illiterate
- Does not have regular access to a cellphone
- Not residing within the catchment area
- Does not provide consent to participate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Text and Voice Messages
Participants will receive text messages and voice messages
|
Participants in this study arm will periodically receive information regarding antenatal- and postnatal care and family planning services through text and voice messages from the fifth gestational month until the post-partum period of 42 days.
|
|
Eksperimentel: Interactive Phone Call
Participants will receive interactive phone calls
|
Participants in this study arm will receive information regarding antenatal- and postnatal care and family planning services through periodic interactive phone calls from the fifth gestational month until the post-partum period.
|
|
Ingen indgriben: Control
Participants in this arm will not be exposed to any intervention.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postpartum Contraceptive Uptake
Tidsramme: Through study completion, an average of six months
|
Proportion of subjects enrolled in each of the three groups who adopt any modern family planning method to delay next pregnancy
|
Through study completion, an average of six months
|
|
Skilled Birth
Tidsramme: Through study completion, an average of six months
|
Proportion of women who gave birth in a health facility or through a skilled birth professional
|
Through study completion, an average of six months
|
|
Immunisation
Tidsramme: Through study completion, an average of six months
|
Proportion of women reported to immunise the newborn at birth
|
Through study completion, an average of six months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intention to Adopt Modern Contraception
Tidsramme: Through study completion, an average of six months
|
The proportion of subjects enrolled in the program who state that they intend to adopt any modern family planning method to delay their next birth by 24 months (by type contraceptive method and time within 42 days of postpartum period)
|
Through study completion, an average of six months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Xaher Gul, DrPH(c), Marie Stopes Society
- Ledende efterforsker: Waqas Hameed, MSc, Marie Stopes Society
- Ledende efterforsker: Junaid-ur-Rehman Siddiqui, BBA, Marie Stopes Society
- Ledende efterforsker: Sharmeen Hussain, MPH, Marie Stopes Society
- Ledende efterforsker: Ishaque Sheikh, MSc, Marie Stopes Society
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Smith C, Gold J, Ngo TD, Sumpter C, Free C. Mobile phone-based interventions for improving contraception use. Cochrane Database Syst Rev. 2015 Jun 26;2015(6):CD011159. doi: 10.1002/14651858.CD011159.pub2.
- Cleland J, Shah IH, Daniele M. Interventions to Improve Postpartum Family Planning in Low- and Middle-Income Countries: Program Implications and Research Priorities. Stud Fam Plann. 2015 Dec;46(4):423-41. doi: 10.1111/j.1728-4465.2015.00041.x.
- Gul X, Hameed W, Hussain S, Sheikh I, Siddiqui JU. A study protocol for an mHealth, multi-centre randomized control trial to promote use of postpartum contraception amongst rural women in Punjab, Pakistan. BMC Pregnancy Childbirth. 2019 Aug 8;19(1):283. doi: 10.1186/s12884-019-2427-z.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
15. september 2018
Primær færdiggørelse (Forventet)
1. august 2019
Studieafslutning (Forventet)
1. august 2019
Datoer for studieregistrering
Først indsendt
27. juli 2018
Først indsendt, der opfyldte QC-kriterier
1. august 2018
Først opslået (Faktiske)
2. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 009-17
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
IPD will only be shared for underlying results in a publication.
Furthermore, de-identified participant data pertinent only to the research paper will be shared.
IPD-delingstidsramme
Publication
IPD-delingsadgangskriterier
At the time of publication, data will be submitted to a data repository and the URL will be shared with the journal, and the journal will make the information public.
Requests to access data will be individually reviewed by the research team.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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