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Misoprostol Delivers!
The use of misoprostol in the prevention
of postpartum hemorrhage (PPH) in Doti
                           District, Nepal

Implementation and data collection CARE Nepal CRADLE Team
Statistics by Noor Tirmizi and Kristen Yee
Outline

• Background

 Results from Feasibility Study

• Results from Case Control Study on Effectiveness
• Methods
• Results
 • Descriptive statistics
 • Bivariate analysis
 • Logistic regression
• Limitations
• Conclusions
Background: Misoprostol in Doti District, Nepal

                        •   Blanket pilot program initiated in
                            Dec 2010 in Doti
                        •   Hilly, mountainous region, 768
                            sq miles
                        •   Aimed to Provide misoprostol
                            (600μg) to every pregnant
                            women in 8th month of
                            pregnancy
                        •   Training of HWs/FCHV and drug
                            supply facilitated by CARE
                        •   Monitoring and supervision of
                            rollout done by MoH in
                            partnership with CARE
Operations Research Study

To determine
• feasibility
• acceptability
• safety

    of community-based distribution of misoprostol by
    community volunteers under government service towards
    the prevention of postpartum hemorrhage (PPH) in
    pregnant women



3
OR – Feasibility Study
Objectives of the study:
• To explore the utilization pattern of Misoprostol in Doti
  district during delivery.
• To find out results of Misoprostl and list side
  effects/complicatins seen.

Study Design
• A cross section study on feasibility of Misoprostol by
  Recently Delivered Women (RDW)

Sample Size for the study
• 15/ 50 VDCs randomly selected. (1) all the FCHVs of those
 VDC interviewed (2) Recently delivered women (3) Similarly HW and
 HWIC wherever available in these 15 VDCs interviewed.
Study Setting & Design
 Data Collection
• Quantitative collected from the interview of RDW
• Qualitative collected using IDI and FGDs of FCHVs, HWs,
  HFICs

Data processing and analysis
• Data collection tools were coded and analyzed in SPSS
• FGDs/IDIs were transcribed and analyzed using content
  analysis approach

Duration of Data Collection
• August 2011 for both qualitative and quantitative data
Antenatal & Health Education Characteristics
                                 Cases (N=55)       Controls (N=290)
                                         Percent              Percent
      Variable                 Freq                Freq
                                          Freq                 Freq
ANC                   <4       16         28.6     99          34.1
                     visits
                    4 visits   39         71.4     191         65.9
Any counseling on     No       19         34.5     67          23.1
BPP by FCHV
                      Yes      36         65.5     223         76.9
BPP counseling by     No       43         78.2     185         63.8
FCHV in 8th month
of pregnancy
                      Yes      12         21.8     105         36.2
Delivery Characteristics

                                Cases (N=55)      Controls (N=290)
                                        Percent             Percent
     Variable                 Freq                Freq
                                         Freq                Freq
Place of delivery   Home      55         100.0    286         98.6
                    Cowshed    0          0.0      2          0.7

                    Road       0          0.0      2          0.7
HW attended         No        36          64.7    143         49.2
delivery
                    Yes       19          35.3    147         50.8
Source of Information

Knowledge on MSC        Percent (n=169)
Heard about MSC from:
FCHV                         72.2
VHW/MCHW/ANM                 17.8
Doctors/HA/AHW                8.9
OR - The Numbers Game
Feasibility
• 49% Illiterate
• 40% Dalits                    345 Women Interviewed
• 95% women had
FCHV < 30 minute
walk
                                173 Received Misoprostol
Safety
• 88% knew correct timing.
• Common Side Effects             169 took the correct
  vomit, diarrhea, shivering             dose
• 95% knew advice to go to HF
if bleeding persists


         Acceptability: 99.4% of users would recommend MSC
         to their friends and relatives
FGD/IDI Findings
1) MCHW/ANM
• Interview with nursing staffs revealed that FCHVs were capable for
  distribution of MSC and counseling on its usage to mothers.

2) HF- Incharge
• HF in-charges were confident about knowledge of FCHVs on MSC;
  dose, time to take, side effects and its return and their ability to distribute
  the tablets.

3) FCHV
• FCHV reported that they gave the tablets only after enough counseling
  on the dose, time and its general side effects to the mothers.

  Some of the more aware mothers came to ask for the tablets at last
  months of the pregnancy.
Study on Effectiveness of Misoprostol
Objectives:
• Determine the odds of misoprostol ingestion based on receipt
  of pills
• Determine the odds of postpartum hemorrhage based on
  correct ingestion of misoprostol (600μg taken orally
  immediately following childbirth)

Definition:
• PPH – MOH definition – 2 half meter cloths completely soaked
  with blood during delivery.

Cases = RDW women who experienced PPH (n=55)
Controls = RDW women who did not experience PPH (n=290)
Binary Logistic Regression Results
 Effectiveness of MSC reducing PPH
Variable                               Reduction in PPH          CI

                                           Exp (β)
Age
 (15-24) yrs of age                          1.57         0.85        2.79
 25 yrs or older
Ingestion of misoprostol (600 μg)           0.46*         0.25        0.86
Yes

Receipt of Counseling on BPP by FCHV
in 8th month of last pregnancy             0.53**         0.27 1.07
Binary Logistic Regression Results—Factors
Affecting Ingestion of MSC

Variable                 MSC Ingestion          CI
                           Exp (β)
Age
 (15-24) yrs of age          0.95        0.60        1.48
 25 yrs or older
Literacy
 Literate                    1.43        0.91        2.26
ANC Visits
 Did complete 4 visits       1.78*       1.13        2.81
Continued Counseling
 Did not receive any         1.43        0.85        2.40
 counseling
Cross Tables to Explain Reasons for Non-use
Variable
                            Did not take MSC following   Did take immediately
Access                               childbirth           following childbirth
                                    N        (%)              N         (%)


Got MSC tablets during            67      (40.9)            97      (59.1)
pregnancy

Knowledge: Reasons for
taking MSC
Stop PPH, Prevent Death,
help uterus contraction &          114     (54)             95      (45.0)
placenta expulsion
Knowledge on Correct Dose of MSC


Knowledge on dose                Incorrect dose   Correct dose
                                   N       (%)     N      (%)

Reasons for taking MSC

Stop PPH & Prevent Death          15     (8.8)    155    (91.2)

Counseling

Did receive counseling by FCHV   129     (49.8)   130    (50.2)
Limitations

Data collection
• Cross-sectional analysis
• Self-report of misoprostol ingestion and PPH

Data analysis
• Sample size (N=345)
• Proxy measures limit interpretation
Key Findings

• Women who completed four antenatal visits had 1.78 the
  odds of taking misoprostol correctly relative to those
  women who did not complete four antenatal visits

• Women who took misoprostol were associated with a
  53% decrease in the risk of postpartum hemorrhage
Examples from Literature
• BRAC’s maternal, neonatal and child health program in rural
  northern Bangladesh 2008-2010
   • Successfully provided misoprostol (400μg) to mothers under direct
     supervision of CHW
• Maternal and Newborn Health in Ethiopia Partnership
  (MaNHEP)
 • Provides basic package of interventions to mother and child within first
   48 hours of newborn’s life. Misoprostol part of maternal intervention
• The Center for Health Innovations’ Venture Strategies
  Innovation (VSI)
 • Improve misoprostol availability
 • Work with ministries of health to incorporate misoprostol into national
   guidelines and promote task-shifting and training
 • Multi-country initiative, more policy level focus
Conclusions
National Policy Level
• Pilot program initiated by the Government of Nepal and CARE was
  successful. CARE worked with other partners/stakeholders and FHD to
  prepare guidelines for a national program on Misoprostol use. It is a part
  of SMH program in Nepal and is included in the EDL.

  • Program has now been scaled up to function on a national level

• Study findings are consistent with existing literature
  • Misoprostol as a tool in the reduction of postpartum hemorrhage
  • Feasibility and acceptability of misoprotol use and dissemination of the
    community level
  • this study adds to existing evidence in demonstrating that in one of the
    most remote regions of Nepal (hills and mountains), community-level
    distribution of misoprostol is possible
References
•   GULMEZOGLU, A. M., VILLAR, J., NGOC, N. T., PIAGGIO, G., CARROLI, G., ADETORO, L., ABDEL-ALEEM, H., CHENG,
    L., HOFMEYR, G., LUMBIGANON, P., UNGER, C., PRENDIVILLE, W., PINOL, A., ELBOURNE, D., EL-REFAEY, H. &
    SCHULZ, K. 2001. WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet,
    358, 689-95.
•   HASHIMA, E. N., NAHAR, S., AL MAMUN, M., AFSANA, K. & BYASS, P. 2011. Oral misoprostol for preventing postpartum
    haemorrhage in home births in rural Bangladesh: how effective is it? Glob Health Action, 4.
•   HOFMEYR, G. J., GULMEZOGLU, A. M., NOVIKOVA, N., LINDER, V., FERREIRA, S. & PIAGGIO, G. 2009. Misoprostol to
    prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related
    effects. Bull World Health Organ, 87, 666-77.
•   PRATA, N., GESSESSEW, A., ABRAHA, A. K., HOLSTON, M. & POTTS, M. 2009. Prevention of postpartum hemorrhage:
    options for home births in rural Ethiopia. Afr J Reprod Health, 13, 87-95.
•   RAJBHANDARI, S., HODGINS, S., SANGHVI, H., MCPHERSON, R., PRADHAN, Y. V. & BAQUI, A. H. 2010. Expanding
    uterotonic protection following childbirth through community-based distribution of misoprostol: operations research study in
    Nepal. Int J GynaecolObstet, 108, 282-8.
•   HASHIMA, E. N., NAHAR, S., AL MAMUN, M., AFSANA, K. & BYASS, P. 2011. Oral misoprostol for preventing postpartum
    haemorrhage in home births in rural Bangladesh: how effective is it? Glob Health Action, 4.
•   HOFMEYR, G. J., GULMEZOGLU, A. M., NOVIKOVA, N., LINDER, V., FERREIRA, S. & PIAGGIO, G. 2009. Misoprostol to
    prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related
    effects. Bull World Health Organ, 87, 666-77.
•   Maternal and Neonatal Health. Preventing Postpartum Hemorrhage: A community-based approach proves effective in rural
    Indonesia. Baltimore, USA: MNH Program, 2004.
•   PRATA, N., GESSESSEW, A., ABRAHA, A. K., HOLSTON, M. & POTTS, M. 2009. Prevention of postpartum hemorrhage:
    options for home births in rural Ethiopia. Afr J Reprod Health, 13, 87-95.
•   RAJBHANDARI, S., HODGINS, S., SANGHVI, H., MCPHERSON, R., PRADHAN, Y. V. & BAQUI, A. H. 2010. Expanding
    uterotonic protection following childbirth through community-based distribution of misoprostol: operations research study in
    Nepal. Int J GynaecolObstet, 108, 282-8.
•   WORLD HEALTH ORGANIZATION. 2007. WHO recommendations for the prevention of postpartum haemorrhage. Geneva,
    14-15.
Misoprostol Delivers_Roy_5.3.12

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Misoprostol Delivers_Roy_5.3.12

  • 1. Misoprostol Delivers! The use of misoprostol in the prevention of postpartum hemorrhage (PPH) in Doti District, Nepal Implementation and data collection CARE Nepal CRADLE Team Statistics by Noor Tirmizi and Kristen Yee
  • 2. Outline • Background Results from Feasibility Study • Results from Case Control Study on Effectiveness • Methods • Results • Descriptive statistics • Bivariate analysis • Logistic regression • Limitations • Conclusions
  • 3. Background: Misoprostol in Doti District, Nepal • Blanket pilot program initiated in Dec 2010 in Doti • Hilly, mountainous region, 768 sq miles • Aimed to Provide misoprostol (600μg) to every pregnant women in 8th month of pregnancy • Training of HWs/FCHV and drug supply facilitated by CARE • Monitoring and supervision of rollout done by MoH in partnership with CARE
  • 4. Operations Research Study To determine • feasibility • acceptability • safety of community-based distribution of misoprostol by community volunteers under government service towards the prevention of postpartum hemorrhage (PPH) in pregnant women 3
  • 5. OR – Feasibility Study Objectives of the study: • To explore the utilization pattern of Misoprostol in Doti district during delivery. • To find out results of Misoprostl and list side effects/complicatins seen. Study Design • A cross section study on feasibility of Misoprostol by Recently Delivered Women (RDW) Sample Size for the study • 15/ 50 VDCs randomly selected. (1) all the FCHVs of those VDC interviewed (2) Recently delivered women (3) Similarly HW and HWIC wherever available in these 15 VDCs interviewed.
  • 6. Study Setting & Design Data Collection • Quantitative collected from the interview of RDW • Qualitative collected using IDI and FGDs of FCHVs, HWs, HFICs Data processing and analysis • Data collection tools were coded and analyzed in SPSS • FGDs/IDIs were transcribed and analyzed using content analysis approach Duration of Data Collection • August 2011 for both qualitative and quantitative data
  • 7. Antenatal & Health Education Characteristics Cases (N=55) Controls (N=290) Percent Percent Variable Freq Freq Freq Freq ANC <4 16 28.6 99 34.1 visits 4 visits 39 71.4 191 65.9 Any counseling on No 19 34.5 67 23.1 BPP by FCHV Yes 36 65.5 223 76.9 BPP counseling by No 43 78.2 185 63.8 FCHV in 8th month of pregnancy Yes 12 21.8 105 36.2
  • 8. Delivery Characteristics Cases (N=55) Controls (N=290) Percent Percent Variable Freq Freq Freq Freq Place of delivery Home 55 100.0 286 98.6 Cowshed 0 0.0 2 0.7 Road 0 0.0 2 0.7 HW attended No 36 64.7 143 49.2 delivery Yes 19 35.3 147 50.8
  • 9. Source of Information Knowledge on MSC Percent (n=169) Heard about MSC from: FCHV 72.2 VHW/MCHW/ANM 17.8 Doctors/HA/AHW 8.9
  • 10. OR - The Numbers Game Feasibility • 49% Illiterate • 40% Dalits 345 Women Interviewed • 95% women had FCHV < 30 minute walk 173 Received Misoprostol Safety • 88% knew correct timing. • Common Side Effects 169 took the correct vomit, diarrhea, shivering dose • 95% knew advice to go to HF if bleeding persists Acceptability: 99.4% of users would recommend MSC to their friends and relatives
  • 11. FGD/IDI Findings 1) MCHW/ANM • Interview with nursing staffs revealed that FCHVs were capable for distribution of MSC and counseling on its usage to mothers. 2) HF- Incharge • HF in-charges were confident about knowledge of FCHVs on MSC; dose, time to take, side effects and its return and their ability to distribute the tablets. 3) FCHV • FCHV reported that they gave the tablets only after enough counseling on the dose, time and its general side effects to the mothers. Some of the more aware mothers came to ask for the tablets at last months of the pregnancy.
  • 12. Study on Effectiveness of Misoprostol Objectives: • Determine the odds of misoprostol ingestion based on receipt of pills • Determine the odds of postpartum hemorrhage based on correct ingestion of misoprostol (600μg taken orally immediately following childbirth) Definition: • PPH – MOH definition – 2 half meter cloths completely soaked with blood during delivery. Cases = RDW women who experienced PPH (n=55) Controls = RDW women who did not experience PPH (n=290)
  • 13. Binary Logistic Regression Results Effectiveness of MSC reducing PPH Variable Reduction in PPH CI Exp (β) Age (15-24) yrs of age 1.57 0.85 2.79 25 yrs or older Ingestion of misoprostol (600 μg) 0.46* 0.25 0.86 Yes Receipt of Counseling on BPP by FCHV in 8th month of last pregnancy 0.53** 0.27 1.07
  • 14. Binary Logistic Regression Results—Factors Affecting Ingestion of MSC Variable MSC Ingestion CI Exp (β) Age (15-24) yrs of age 0.95 0.60 1.48 25 yrs or older Literacy Literate 1.43 0.91 2.26 ANC Visits Did complete 4 visits 1.78* 1.13 2.81 Continued Counseling Did not receive any 1.43 0.85 2.40 counseling
  • 15. Cross Tables to Explain Reasons for Non-use Variable Did not take MSC following Did take immediately Access childbirth following childbirth N (%) N (%) Got MSC tablets during 67 (40.9) 97 (59.1) pregnancy Knowledge: Reasons for taking MSC Stop PPH, Prevent Death, help uterus contraction & 114 (54) 95 (45.0) placenta expulsion
  • 16. Knowledge on Correct Dose of MSC Knowledge on dose Incorrect dose Correct dose N (%) N (%) Reasons for taking MSC Stop PPH & Prevent Death 15 (8.8) 155 (91.2) Counseling Did receive counseling by FCHV 129 (49.8) 130 (50.2)
  • 17. Limitations Data collection • Cross-sectional analysis • Self-report of misoprostol ingestion and PPH Data analysis • Sample size (N=345) • Proxy measures limit interpretation
  • 18. Key Findings • Women who completed four antenatal visits had 1.78 the odds of taking misoprostol correctly relative to those women who did not complete four antenatal visits • Women who took misoprostol were associated with a 53% decrease in the risk of postpartum hemorrhage
  • 19. Examples from Literature • BRAC’s maternal, neonatal and child health program in rural northern Bangladesh 2008-2010 • Successfully provided misoprostol (400μg) to mothers under direct supervision of CHW • Maternal and Newborn Health in Ethiopia Partnership (MaNHEP) • Provides basic package of interventions to mother and child within first 48 hours of newborn’s life. Misoprostol part of maternal intervention • The Center for Health Innovations’ Venture Strategies Innovation (VSI) • Improve misoprostol availability • Work with ministries of health to incorporate misoprostol into national guidelines and promote task-shifting and training • Multi-country initiative, more policy level focus
  • 20. Conclusions National Policy Level • Pilot program initiated by the Government of Nepal and CARE was successful. CARE worked with other partners/stakeholders and FHD to prepare guidelines for a national program on Misoprostol use. It is a part of SMH program in Nepal and is included in the EDL. • Program has now been scaled up to function on a national level • Study findings are consistent with existing literature • Misoprostol as a tool in the reduction of postpartum hemorrhage • Feasibility and acceptability of misoprotol use and dissemination of the community level • this study adds to existing evidence in demonstrating that in one of the most remote regions of Nepal (hills and mountains), community-level distribution of misoprostol is possible
  • 21. References • GULMEZOGLU, A. M., VILLAR, J., NGOC, N. T., PIAGGIO, G., CARROLI, G., ADETORO, L., ABDEL-ALEEM, H., CHENG, L., HOFMEYR, G., LUMBIGANON, P., UNGER, C., PRENDIVILLE, W., PINOL, A., ELBOURNE, D., EL-REFAEY, H. & SCHULZ, K. 2001. WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet, 358, 689-95. • HASHIMA, E. N., NAHAR, S., AL MAMUN, M., AFSANA, K. & BYASS, P. 2011. Oral misoprostol for preventing postpartum haemorrhage in home births in rural Bangladesh: how effective is it? Glob Health Action, 4. • HOFMEYR, G. J., GULMEZOGLU, A. M., NOVIKOVA, N., LINDER, V., FERREIRA, S. & PIAGGIO, G. 2009. Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects. Bull World Health Organ, 87, 666-77. • PRATA, N., GESSESSEW, A., ABRAHA, A. K., HOLSTON, M. & POTTS, M. 2009. Prevention of postpartum hemorrhage: options for home births in rural Ethiopia. Afr J Reprod Health, 13, 87-95. • RAJBHANDARI, S., HODGINS, S., SANGHVI, H., MCPHERSON, R., PRADHAN, Y. V. & BAQUI, A. H. 2010. Expanding uterotonic protection following childbirth through community-based distribution of misoprostol: operations research study in Nepal. Int J GynaecolObstet, 108, 282-8. • HASHIMA, E. N., NAHAR, S., AL MAMUN, M., AFSANA, K. & BYASS, P. 2011. Oral misoprostol for preventing postpartum haemorrhage in home births in rural Bangladesh: how effective is it? Glob Health Action, 4. • HOFMEYR, G. J., GULMEZOGLU, A. M., NOVIKOVA, N., LINDER, V., FERREIRA, S. & PIAGGIO, G. 2009. Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects. Bull World Health Organ, 87, 666-77. • Maternal and Neonatal Health. Preventing Postpartum Hemorrhage: A community-based approach proves effective in rural Indonesia. Baltimore, USA: MNH Program, 2004. • PRATA, N., GESSESSEW, A., ABRAHA, A. K., HOLSTON, M. & POTTS, M. 2009. Prevention of postpartum hemorrhage: options for home births in rural Ethiopia. Afr J Reprod Health, 13, 87-95. • RAJBHANDARI, S., HODGINS, S., SANGHVI, H., MCPHERSON, R., PRADHAN, Y. V. & BAQUI, A. H. 2010. Expanding uterotonic protection following childbirth through community-based distribution of misoprostol: operations research study in Nepal. Int J GynaecolObstet, 108, 282-8. • WORLD HEALTH ORGANIZATION. 2007. WHO recommendations for the prevention of postpartum haemorrhage. Geneva, 14-15.

Notas del editor

  1. Based on low number of health facilities and health providers in Nepal, especially in Doti District, which is in the mountainous Far Western Region, MoH decided to pilot Provide misoprostol to women late in pregnancy, to be taken immediately after delivery, for births not attended by a skilled providerSystem was MoH’sSee operations research paper p.4 seems pills were distributed from Dec 2010-April 2011. Started community-level distribution in Dec (what does this mean??) and then stopped in April w/ pills expired in June and the government failed to renew stocks Provided to women in the last yr of the project, would have liked to have paid more attn to it, but couldn’t for this reason
  2. Focus on ingestion of MSC and PPH today; feasibility and acceptability was done by CARE Nepal team
  3. Restricted to Doti District, Far Western RegionPlains study done, but none done in the hills and mountains, roads poor, few health facilities, few health workers, would this still work here? Self-report of ingestion of matrusurakshachakki – translates to maternal protection tablets and PPHSurvey pilot tested in Khrisain VDC, which was not selected in the randomized process-definition of PPH was soaked pads (-same named as used in Rajbhandari study
  4. Nepal family health program – miso coverage 53% (estimated pregnancies = 16000, received MSC 11685, 53% of these took miso)
  5. Descriptive statistics presented in operations research report by field team in Nepal; I will show you relevant stats for our purposes hereThis is subsequent analysis of data. Objectives here were:
  6. Proxy – i.e. use of receipt of counseling at 8M rather than knowing exact time point when women were given pills.
  7. Some studies show a reduction in risk of PPH as high as 79%FCHV one – possible misclassification/missed cases. FCHVs are often present at ANC visits, when women don’t come for ANC visit, FCHVs go to them at home. Could be that this question wasn’t clear.
  8. BRAC – paper is among those I sent you when I was doing the lit reviewhttp://www.nursing.emory.edu/manhep/index.htmlhttp://healthmarketinnovations.org/program/venture-strategies-innovations-vsi