ContraceptionNCT02718222
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
A study testing Post-partum IUD in people with Contraception, run by Harvard School of Public Health (HSPH) at 3 sites in 3 countries.
Trial summary
Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Post-partum IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140,258 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2015to Dec 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Delivered in intervention hospital during 12-month enrollment period (Tanzania)/18-month enrollment period (Nepal and Sri Lanka)
Who cannot join
- Does not live in the country where delivered
- Tanzania only: Under age 18
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Nepal1 site
Center for Research on Enviornment Health and Population Activities
Kathmandu
Sri Lanka1 site
Sri Lanka College of Obstetricians and Gynecologists
Colombo
About this study
Official title: Studying the Impact and Performance of Institutionalizing Immediate Post-partum IUD Services as a Routine Part of Antenatal Counseling and Delivery Room Services in Nepal, Sri Lanka, Tanzania
Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.
Read the detailed description
The International Federation of Gynaecology and Obstetrics (FIGO) has designed and is planning to implement, through its nationally-affiliated Associations of Gynaecologists and Obstetricians, an intervention program on post-partum IUD (PPIUD) services. As part of this Program, FIGO is responsible for information material, training providers, improving facilities, quality of service, and monitoring the program. Independent of the implementation, this study will measure the impact and performance of this intervention in three (Sri Lanka, Nepal and Tanzania) of the six countries participating in the FIGO project entitled: "Institutionalization of immediate post-partum IUD (PPIUD) services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Kenya, India, Tanzania, Nepal and Bangladesh." The FIGO intervention will take place over a nine-month period in Tanzania (nine months in the first group of three hospitals and three months in the second group of three hospitals), and over a fifteen-month period in Nepal and Sri Lanka (fifteen months in the first group of three hospitals and nine months in the second group of three hospitals). Investigators will study both the impact of the intervention on the uptake and subsequent continued use of PPIUD and the extent to which the intervention leads to the institutionalization of postpartum IUD services in the hospitals during and after the FIGO intervention and to what extent the service diffuses to other hospitals or providers. The institutionalization and diffusion of the intervention will be measured by interviewing and following up trained providers, review of hospital records and baseline, during intervention and post-intervention facility surveys.
- Conditions
- Contraception
- Being tested
- Post-partum IUD
- Keywords
- Post-partum intrauterine device (PPIUD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-partum IUDDevice
Also called PPIUD
The PPIUD intervention aims to address the postpartum contraceptive needs of women by training community midwives, health workers, doctors and delivery unit staff in postpartum IUD counselling and insertion.
| Study group | Role | What they receive |
|---|---|---|
| 3-9 months PPIUD intervention | Experimental | Tanzania: Baseline (no intervention) period is 9 months. Post-partum IUD intervention begins after 9 months and continues for 3 months.
Nepal and Sri Lanka: Baseline (no intervention) period is 9 months. Post-partum IUD intervention begins after 9 months and continues for 9 months. Receives: Device: Post-partum IUD |
| 9-15 months PPIUD intervention | Experimental | Tanzania: Baseline (no intervention) period is 3 months. Post-partum IUD intervention begins after 3 months and continues for 9 months.
Nepal and Sri Lanka: Baseline (no intervention) period is 3 months. Post-partum IUD intervention begins after 3 months and continues for 15 months. Receives: Device: Post-partum IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage uptake of PPIUD
To ascertain what percentage of women delivering in study hospitals take uptake PPIUD, participants will be interviewed after delivery, before they are discharged from the hospital.
Measured: Within approximately 24 hours postpartum, before discharge from the hospital.
Secondary outcomes (5)
Percentage of women receiving PPIUD counseling
To ascertain what percentage of women delivering in study hospitals receive counseling on PPIUD, participants will be interviewed after delivery, before they are discharged from the hospital.
Measured: Within approximately 24 hours postpartum, before discharge from the hospital.
Percentage of PPIUD acceptors who have expulsions at 4-6 weeks postpartum
Participants who have not deliberately removed the PPIUD will be examined by providers at 4-6 weeks postpartum, and providers will report whether the PPIUD was expelled.
Measured: 6 weeks postpartum
Percentage of women using modern contraception at 9 months postpartum
Participants will be interviewed at 9 months and asked whether they are using a modern method of contraception.
Measured: 9 months postpartum
Percentage of women using modern contraception at 18 months postpartum
Participants will be interviewed at 18 months and asked whether they are using a modern method of contraception.
Measured: 18 months postpartum
Percentage of women pregnant at 18 months postpartum
Participants will be interviewed at 18 months and asked whether they are pregnant.
Measured: 18 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 140,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- International Federation of Gynaecology and Obstetrics
- Responsible party
- Principal investigator, Iqbal Shah, Harvard School of Public Health (HSPH)
- Investigators
- Iqbal H Shah, PhD, Principal investigator, Harvard School of Public Health (HSPH)David Canning, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718222
- Sponsor's protocol ID
- 6904190-01
- Status last verified
- Aug 2019
- First submitted
- 11 Mar 2016
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Investigators intend to make a de-identified dataset available after conclusion of the study.
Publications
Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.
PubMed 20961442Hernan MA, Brumback B, Robins JM. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology. 2000 Sep;11(5):561-70. doi: 10.1097/00001648-200009000-00012.
PubMed 10955409Gong Q, Schaubel DE. Partly conditional estimation of the effect of a time-dependent factor in the presence of dependent censoring. Biometrics. 2013 Jun;69(2):338-47. doi: 10.1111/biom.12023. Epub 2013 May 2.
PubMed 23635094Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.
PubMed 17046378Govindarajulu US, Spiegelman D, Thurston SW, Ganguli B, Eisen EA. Comparing smoothing techniques in Cox models for exposure-response relationships. Stat Med. 2007 Sep 10;26(20):3735-52. doi: 10.1002/sim.2848.
PubMed 17538974Ross John A. and Winfrey William L. Contraceptive use, intention to use and unmet need during the extended postpartum period. International Family Planning Perspectives, 2001, 27(1): 20-27.
Rotnitzky A, Robins JM. Semiparametric regression estimation in the presence of dependent censoring. Biometrika. 1995 Dec;82(4):805-20.
Winfrey, William and Rakesh Kshitiz. Use of Family Planning in Postpartum Period. DHS Comparative Report No. 36. 2014. Rockville, Maryland, USA: ICF International.
World Health Organization. Medical Eligibility Criteria for Contraceptive use: Fourth Edition, 2009. 2010. Geneva: World Health Organization.
Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.
PubMed 20966692Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009 Oct;80(4):327-36. doi: 10.1016/j.contraception.2009.03.024. Epub 2009 Aug 29.
PubMed 19751855Grimes DA, Lopez LM, Schulz KF, Stanwood NL. Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001777. doi: 10.1002/14651858.CD001777.pub3.
PubMed 20556754McKaig, Catherine and Blanchard, Holly. The IUD: A contraceptive option for postpartum and postabortion women. Access/USAID.
Mohamed SA, Kamel MA, Shaaban OM, Salem HT. Acceptability for the use of postpartum intrauterine contraceptive devices: Assiut experience. Med Princ Pract. 2003 Jul-Sep;12(3):170-5. doi: 10.1159/000070754.
PubMed 12766335Bryant AG, Kamanga G, Stuart GS, Haddad LB, Meguid T, Mhango C. Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial. Afr J Reprod Health. 2013 Jun;17(2):72-9.
PubMed 24069753
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Impact and Performance of Institutionalizing Immediate Post-partum IUD Services as a Routine Part of Antenatal Counseling and Delivery Room Services in Nepal, Sri Lanka, Tanzania
- ClinicalTrials.gov ID
- NCT02718222
- Acronym / sponsor ID
- 6904190-01
- Conditions
- Contraception
- Keywords
- Post-partum intrauterine device (PPIUD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140,258 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- International Federation of Gynaecology and Obstetrics
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.
Detailed description
The International Federation of Gynaecology and Obstetrics (FIGO) has designed and is planning to implement, through its nationally-affiliated Associations of Gynaecologists and Obstetricians, an intervention program on post-partum IUD (PPIUD) services. As part of this Program, FIGO is responsible for information material, training providers, improving facilities, quality of service, and monitoring the program. Independent of the implementation, this study will measure the impact and performance of this intervention in three (Sri Lanka, Nepal and Tanzania) of the six countries participating in the FIGO project entitled: "Institutionalization of immediate post-partum IUD (PPIUD) services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Kenya, India, Tanzania, Nepal and Bangladesh." The FIGO intervention will take place over a nine-month period in Tanzania (nine months in the first group of three hospitals and three months in the second group of three hospitals), and over a fifteen-month period in Nepal and Sri Lanka (fifteen months in the first group of three hospitals and nine months in the second group of three hospitals). Investigators will study both the impact of the intervention on the uptake and subsequent continued use of PPIUD and the extent to which the intervention leads to the institutionalization of postpartum IUD services in the hospitals during and after the FIGO intervention and to what extent the service diffuses to other hospitals or providers. The institutionalization and diffusion of the intervention will be measured by interviewing and following up trained providers, review of hospital records and baseline, during intervention and post-intervention facility surveys.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-9 months PPIUD intervention | Experimental | Device: Post-partum IUDTanzania: Baseline (no intervention) period is 9 months. Post-partum IUD intervention begins after 9 months and continues for 3 months. Nepal and Sri Lanka: Baseline (no intervention) period is 9 months. Post-partum IUD intervention begins after 9 months and continues for 9 months. |
| 9-15 months PPIUD intervention | Experimental | Device: Post-partum IUDTanzania: Baseline (no intervention) period is 3 months. Post-partum IUD intervention begins after 3 months and continues for 9 months. Nepal and Sri Lanka: Baseline (no intervention) period is 3 months. Post-partum IUD intervention begins after 3 months and continues for 15 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Delivered in intervention hospital during 12-month enrollment period (Tanzania)/18-month enrollment period (Nepal and Sri Lanka)
Key exclusion criteria (2 listed)
- Does not live in the country where delivered
- Tanzania only: Under age 18
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 |
|---|---|---|
| Post-partum IUDAlso: PPIUDThe PPIUD intervention aims to address the postpartum contraceptive needs of women by training community midwives, health workers, doctors and delivery unit staff in postpartum IUD counselling and insertion. | Device | 3-9 months PPIUD intervention, 9-15 months PPIUD intervention |
Primary outcome
Percentage uptake of PPIUD
Time frame: Within approximately 24 hours postpartum, before discharge from the hospital.
To ascertain what percentage of women delivering in study hospitals take uptake PPIUD, participants will be interviewed after delivery, before they are discharged from the hospital.
5 secondary outcomes
Percentage of women receiving PPIUD counseling
Time frame: Within approximately 24 hours postpartum, before discharge from the hospital.
Percentage of PPIUD acceptors who have expulsions at 4-6 weeks postpartum
Time frame: 6 weeks postpartum
Percentage of women using modern contraception at 9 months postpartum
Time frame: 9 months postpartum
Percentage of women using modern contraception at 18 months postpartum
Time frame: 18 months postpartum
Percentage of women pregnant at 18 months postpartum
Time frame: 18 months postpartum
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 8 Aug 2019.
- Background: PubMed 20961442Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.
- Background: PubMed 10955409Hernan MA, Brumback B, Robins JM. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology. 2000 Sep;11(5):561-70. doi: 10.1097/00001648-200009000-00012.
- Background: PubMed 23635094Gong Q, Schaubel DE. Partly conditional estimation of the effect of a time-dependent factor in the presence of dependent censoring. Biometrics. 2013 Jun;69(2):338-47. doi: 10.1111/biom.12023. Epub 2013 May 2.
- Background: PubMed 17046378Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.
- Background: PubMed 17538974Govindarajulu US, Spiegelman D, Thurston SW, Ganguli B, Eisen EA. Comparing smoothing techniques in Cox models for exposure-response relationships. Stat Med. 2007 Sep 10;26(20):3735-52. doi: 10.1002/sim.2848.
- BackgroundRoss John A. and Winfrey William L. Contraceptive use, intention to use and unmet need during the extended postpartum period. International Family Planning Perspectives, 2001, 27(1): 20-27.
- BackgroundRotnitzky A, Robins JM. Semiparametric regression estimation in the presence of dependent censoring. Biometrika. 1995 Dec;82(4):805-20.
- BackgroundWinfrey, William and Rakesh Kshitiz. Use of Family Planning in Postpartum Period. DHS Comparative Report No. 36. 2014. Rockville, Maryland, USA: ICF International.
- BackgroundWorld Health Organization. Medical Eligibility Criteria for Contraceptive use: Fourth Edition, 2009. 2010. Geneva: World Health Organization.
- Background: PubMed 20966692Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.
- Background: PubMed 19751855Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009 Oct;80(4):327-36. doi: 10.1016/j.contraception.2009.03.024. Epub 2009 Aug 29.
- Background: PubMed 20556754Grimes DA, Lopez LM, Schulz KF, Stanwood NL. Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001777. doi: 10.1002/14651858.CD001777.pub3.
- Individual participant dataSharing planned: Yes. Investigators intend to make a de-identified dataset available after conclusion of the study.
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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.
Iqbal H Shah, PhD principal investigator
Harvard School of Public Health (HSPH)
David Canning, PhD principal investigator
Harvard School of Public Health (HSPH)
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-partum IUD in people with Contraception, run by Harvard School of Public Health (HSPH) at 3 sites in 3 countries.
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 1 inclusion and 2 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nepal, Sri Lanka, Tanzania. 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?
Percentage uptake of PPIUD (time frame: Within approximately 24 hours postpartum, before discharge from the hospital.). 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 NCT02718222, which also lists 26 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 8 Aug 2019.