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OpenTrials
Completed

NCT Number: NCT01199601

Blood-borne Infection Screening in an Afghan Antenatal Population

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.

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Key information

Conditions

Viral Hepatitis B Behavior Blood-Borne Infections Breast Feeding Breast Feeding, Exclusive Communicable Diseases Contraception DNA Virus Infections Digestive System Diseases Effects of; Lack of Care of Infants Feeding Behavior Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity Hospitals

Kabul, Afghanistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • admitted for obstetric care
  • Dari or Pashto speaking
  • not previously participated in the study
  • in medically stable condition
  • accompanied by and have approval of a spouse
  • able to provide informed consent

Male participants must be the confirmed spouses of the female participants, have a working telephone, and able to provide informed consent.

Exclusion criteria

  • medically unstable or imminently delivering (complete cervical dilation)
  • husband unavailable or does not approve participation
  • unable to provide consent

Treatment and study plan

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.

Primary outcomes

  1. Utilization of Postpartum Contraception

    Time frame: 12 months

    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.

Secondary outcomes

  1. Correct Breastfeeding Practices to 1 Year

    Time frame: 12 months

    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.

  2. Completion of 9 Month Measles-mumps-rubella Vaccination on Time.

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

Pilot Educational Intervention to Determine Effect of Intrapartum Testing and Concentrated Postpartum Counseling on Birth Spacing, Breastfeeding, and Infant Vaccination Completion in a Kabul Urban Population.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 13, 2010
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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