An interventional study of Concentrated postpartum counseling in Viral Hepatitis B, Contraception and Breast Feeding, Exclusive, sponsored by Columbia University. Completed at 1 site in Afghanistan. Open to participants aged 14 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Columbia University · Not applicable, Interventional, and Other
Baseline information indicates there are measurable levels of hepatitis B SAg and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize hospitals to assess the following aims:
Aim 1: To determine whether the re-training and assignment of health care providers dedicated to intrapartum rapid testing and post-partum counseling will positively impact maternal and neonatal health indicators as compared to utilization of existing health providers for these services among women delivering in publish health maternity hospitals in Kabul, Afghanistan.
Aim 2: To assess whether patients randomized to the intervention and their spouses perceive value in concentrated post-partum counseling.
Aim 3: To investigate whether an intervention providing immediate post-partum provision of a long-acting family planning method would be feasible and acceptable to both men and women in Kabul, Afghanistan.
Outcomes are assessed through questionnaire responses and inspection of vaccination cards at six month intervals by trained study staff through one year total study time. Differences between groups will be assessed with generalized linear mixed modeling. Information obtained to address Aim 3 will be gathered at the 12 month follow-up and analyzed with simple proportions and Chi-square test to assess differences between sexes and other socioeconomic indicators.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's enrollment of 1,291 is above the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male participants must be the confirmed spouses of the female participants, have a working telephone, and able to provide informed consent.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women randomized to receiving concentrated postpartum counseling from the retrained provider.
Behavioral: Concentrated postpartum counseling
Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care.
Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination.
Utilization of Postpartum Contraception
Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.
Time frame: 12 months
Correct Breastfeeding Practices to 1 Year
Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.
Time frame: 12 months
Completion of 9 Month Measles-mumps-rubella Vaccination on Time.
Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.
Time frame: 12 months
Women in active labor able to provide consent recruited by random number designation at four Kabul public maternity hospitals following admission. Recruitment occurred from June 2008 through January 2009.
| Milestone | Counseling Existing Providers | Counseling, Retrained Provider |
|---|---|---|
| Started | 422 | 422 |
| Completed | 353 | 344 |
| Not completed | 69 | 78 |
| Withdrew: Lost to follow-up | 47 | 66 |
| Withdrew: Withdrawal by subject | 15 | 3 |
| Withdrew: Insecurity prevented staff interviewing. | 7 | 9 |
Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.
| participants | Counseling Existing Providers | Counseling, Retrained Provider |
|---|---|---|
| Utilization of Postpartum Contraception | 199 | 213 |
Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.
| participants | Counseling Existing Providers | Counseling, Retrained Provider |
|---|---|---|
| Correct Breastfeeding Practices to 1 Year | 198 | 240 |
Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.
| participants | Counseling Existing Providers | Counseling, Retrained Provider |
|---|---|---|
| Completion of 9 Month Measles-mumps-rubella Vaccination on Time. | 211 | 235 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Counseling Existing Providers | — | 0/422 (0%) | 0/422 (0%) |
| Counseling, Retrained Provider | — | 0/422 (0%) | 0/422 (0%) |
The 1291 reflects the husbands interviewed at 12 months (n=447). The husbands were not analyzed as part of the RCT.
| Age, Categorical(Participants) | Counseling Existing Providers | Counseling, Retrained Provider | Total |
|---|---|---|---|
| <=18 years | 34 | 31 | 65 |
| Between 18 and 65 years | 388 | 391 | 779 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Counseling Existing Providers | Counseling, Retrained Provider | Total |
|---|---|---|---|
| Mean | 25.1 ± 5.6 | 24.8 ± 5.5 | 24.9 ± 5.5 |
| Sex: Female, Male(Participants) | Counseling Existing Providers | Counseling, Retrained Provider | Total |
|---|---|---|---|
| Female | 422 | 422 | 844 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Counseling Existing Providers | Counseling, Retrained Provider | Total |
|---|---|---|---|
| Afghanistan | 422 | 422 | 844 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.