Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 7K01TW007408-04 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concentrated postpartum counseling | Experimental | Women randomized to receiving concentrated postpartum counseling from the retrained provider. |
|
| Routine postpartum counseling | No Intervention | Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concentrated postpartum counseling | Behavioral | Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
Not provided
Inclusion Criteria:
Male participants must be the confirmed spouses of the female participants, have a working telephone, and able to provide informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Todd, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity Hospitals | Kabul | Afghanistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Counseling Existing Providers | Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers of same professional cadre as intervention group. Intrapartum, postpartum counseling : Intrapartum testing and routine counseling package provided by study. |
| FG001 | Counseling, Retrained Provider | Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention) Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The 1291 reflects the husbands interviewed at 12 months (n=447). The husbands were not analyzed as part of the RCT.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Counseling Existing Providers | Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) . Intrapartum, postpartum counseling : Intrapartum testing and routine counseling. |
| BG001 | Counseling, Retrained Provider |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants included in analysis were those completing the 6 and 12 month follow-up visits. | Posted | Number | participants | 12 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Counseling Existing Providers | Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group. Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Todd | Columbia University | 212-305-4805 | cst2121@columbia.edu |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 12 months |
| Insecurity prevented staff interviewing. |
|
Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group). Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Counseling, Retrained Provider | Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider |
|
|
|
| Secondary | 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. | Posted | Number | participants | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Number | participants | 12 months |
|
|
|
|
| 0 |
| 422 |
| 0 |
| 422 |
| EG001 | Counseling, Retrained Provider | Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider | 0 | 422 | 0 | 422 |
Not provided
Not provided
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |