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試験進捗状況 主たる結果の公表済み/Main results already published
UMIN試験ID UMIN000031789
受付番号 R000036286
科学的試験名 バングラデシュ国における母性保護サービス強化プロジェクト(SMPP)フェーズ2の評価研究
一般公開日(本登録希望日) 2018/05/31
最終更新日 2019/09/20

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title バングラデシュ国における母性保護サービス強化プロジェクト(SMPP)フェーズ2の評価研究 Interventional study on the impact of safe motherhood promotion project Phase II in Bangladesh
一般向け試験名略称/Acronym バングラデシュ国におけるSMPP評価研究 JICA SMPP II in Bangladesh
科学的試験名/Scientific Title バングラデシュ国における母性保護サービス強化プロジェクト(SMPP)フェーズ2の評価研究 Interventional study on the impact of safe motherhood promotion project Phase II in Bangladesh
科学的試験名略称/Scientific Title:Acronym バングラデシュ国におけるSMPP評価研究 JICA SMPP II in Bangladesh
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition 母子保健指標 Maternal and neonatal health indicators
疾患区分1/Classification by specialty
該当せず/Not applicable
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 バングラデシュ国シャトキラ県コラロア郡で実施されたSMPPの介入の母子保健サービス利用や母子保健指標の改善に関する効果を検証する。 To assess the effectiveness of SMPP intervention in Kalaroa Upazila, Satkhira District on improving maternal and neonatal indicators and service utilization
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes ・研究対象となる妊婦が妊娠期間中に専門の技能を持つスタッフによる健診を4回以上を受ける割合;
・専門の技能を持つスタッフの介助による分娩を受ける割合;
・施設分娩の割合;
・産科救急ケアの利用率;
・専門の技能を持つスタッフによる産後ケアの普及率;
・新生児の疾患が起こる場合、専門の技能を持つスタッフによる新生児ケアサービスを受ける割合
- Proportion of targeted women (recently delivered women) received 4 or more ANC by skilled providers;
- Proportion of deliveries attended by skilled birth attendants
- Proportion of deliveries conducted at the health facilities (both public and private)
- Proportion of women with complications during pregnancy/delivery/postpartum period utilized EmOC services (met need)
- Proportion of targeted women received PNC within 42 days of delivery by skilled providers
- Proportion of mother&babies received neonatal care services from trained health providers (or health facilities) during neonatal sickness
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 集団/Cluster
ブラインド化/Blinding オープンだが測定者がブラインド化されている/Open -but assessor(s) are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification はい/YES
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 知る必要がない/No need to know

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 教育・カウンセリング・トレーニング/Educational,Counseling,Training
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/Interventions/Control_1 母子保健サービス提供者のスキル・能力強化;
住民の組織化による主体的な安全なお産活動;
病院における母子保健サービスの質の改善;
地方行政機関との連携による母子保健啓発活動;
母子保健関連グッドプラクティスの他地域への普及・政策化
Safe Motherhood Promotion through organizing communities,
Improvement of quality MNH services at hospitals,
Collaboration with local government bodies to mainstream MNH,
Replication and policy development of good practices related to MNH
介入2/Interventions/Control_2 対照群は既存のサービスパッケージを実施 The current service package
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
15 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
49 歳/years-old 以下/>=
性別/Gender 女/Female
選択基準/Key inclusion criteria 対象地域で過去1年に出産を経験した女性(死産を含む) Women who had child birth during last one year in the targeted areas.
除外基準/Key exclusion criteria 本プロジェクトに参加する意思がなし Not willing to participate in the project
目標参加者数/Target sample size 2500

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
幸江
ミドルネーム
吉村
Yukie
ミドルネーム
Yoshimura
所属組織/Organization 日本国際協力機構 Japan International Cooperation Agency
所属部署/Division name バングラデシュ事務所 Bangladesh Office
郵便番号/Zip code 1212
住所/Address 3rd Floor, Bay's Galleria, 57 Gulshan Avenue, Gulshan 1, Dhaka 1212, Bangladesh 3rd Floor, Bay's Galleria, 57 Gulshan Avenue, Gulshan 1, Dhaka 1212, Bangladesh
電話/TEL +880-2-989-1897
Email/Email yoshiboubd@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
若エン
ミドルネーム
Ruoyan
ミドルネーム
Gai
組織名/Organization 国立成育医療研究センター National Center for Child Health and Development
部署名/Division name 政策科学研究部 Department of Health Policy
郵便番号/Zip code 1578535
住所/Address 東京都世田谷区大蔵2-10-1 Okura 2-10-1, Setagaya, Tokyo
電話/TEL +81.3.3416.0181
試験のホームページURL/Homepage URL
Email/Email gai-r@ncchd.go.jp

実施責任組織/Sponsor
機関名/Institute 独立行政法人国際協力機構(研究所) Japan International Cooperation Agency
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization 独立行政法人国際協力機構(研究所) Japan International Cooperation Agency (JICA)
機関名/Organization
(機関選択不可の場合)
独立行政法人国際協力機構
組織名/Division
組織の区分/Category of Funding Organization 日本の官庁/Japanese Governmental office
研究費拠出国/Nationality of Funding Organization 日本 Japan

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor 国立成育医療研究センター National Center for Child Health and Development
その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 国立成育医療研究センター National Center for Child Health and Development
住所/Address 東京都世田谷区大蔵2-10-1 Okura 2-10-1, Setagaya-ku, Tokyo 1578535 Japan
電話/Tel 0334160181
Email/Email gai-r@ncchd.go.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 05 31

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394907/
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394907/
組み入れ参加者数/Number of participants that the trial has enrolled 4675
主な結果/Results The major indicators of the utilization of maternal and neonatal care among pregnant women with different wealth status showed significant improvement after the intervention. The impacts of the intervention were in particular significant among the women of 2nd and 3rd quintiles of household wealth status. The use of CCs increased after the intervention and private hospitals / clinics served as the major health providers. The study also identified increased practices of cesarean section. The major indicators of the utilization of maternal and neonatal care among pregnant women with different wealth status showed significant improvement after the intervention. The impacts of the intervention were in particular significant among the women of 2nd and 3rd quintiles of household wealth status. The use of CCs increased after the intervention and private hospitals / clinics served as the major health providers. The study also identified increased practices of cesarean section.
主な結果入力日/Results date posted
2019 09 20
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
2019 02 28
参加者背景/Baseline Characteristics The study participant eligibility criteria was: women who had a birth during one year preceding the baseline and end-line data collection, resided in the intervention and control areas, and agreed to participate in the study with the written informed consent. The study participant eligibility criteria was: women who had a birth during one year preceding the baseline and end-line data collection, resided in the intervention and control areas, and agreed to participate in the study with the written informed consent.
参加者の流れ/Participant flow The two surveys collected data from 2,339 and 2,336 women who reside in Kalaroa upazila and gave birth in the preceding year of data collection (between 1 June 2011 and 31 May 2012 and between 1 July 2014 and 30 June 2015, respectively). The unit of randomization in this study was a CC in unions (the lowest administrative unit of local government) that covers about 6,000 population in its catchment area. The two surveys collected data from 2,339 and 2,336 women who reside in Kalaroa upazila and gave birth in the preceding year of data collection (between 1 June 2011 and 31 May 2012 and between 1 July 2014 and 30 June 2015, respectively). The unit of randomization in this study was a CC in unions (the lowest administrative unit of local government) that covers about 6,000 population in its catchment area.
有害事象/Adverse events Not applicable Not applicable
評価項目/Outcome measures The expected outcome of this study was increased utilization of services for antenatal, delivery, postpartum and neonatal care by the pregnant and post-partum women. We examined the proportion of women received those services provided by skilled health personnels including Community-based Skilled Birth Attendants (CSBA), Family Welfare Visitors (FWV), nurses and doctors, and at health facilities (both public and private).

The major indicators of the expected outcomes were:

- Proportion of women received any and 4+ ANC from skilled health care providers;

- Met need (proportion of women with complications received services from EmOC facilities) during pregnancy, childbirth and post-partum period;

- Delivery attended by skilled birth attendants;

- Delivery conducted at health facilities;

- Proportion of postpartum women received PNC from skilled providers within 42 days of delivery;

- Proportion of sick newborns received services from skilled provider.
The expected outcome of this study was increased utilization of services for antenatal, delivery, postpartum and neonatal care by the pregnant and post-partum women. We examined the proportion of women received those services provided by skilled health personnels including Community-based Skilled Birth Attendants (CSBA), Family Welfare Visitors (FWV), nurses and doctors, and at health facilities (both public and private).

The major indicators of the expected outcomes were:

- Proportion of women received any and 4+ ANC from skilled health care providers;

- Met need (proportion of women with complications received services from EmOC facilities) during pregnancy, childbirth and post-partum period;

- Delivery attended by skilled birth attendants;

- Delivery conducted at health facilities;

- Proportion of postpartum women received PNC from skilled providers within 42 days of delivery;

- Proportion of sick newborns received services from skilled provider.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 主たる結果の公表済み/Main results already published
プロトコル確定日/Date of protocol fixation
2011 05 29
倫理委員会による承認日/Date of IRB
2018 03 14
登録・組入れ開始(予定)日/Anticipated trial start date
2011 07 01
フォロー終了(予定)日/Last follow-up date
2016 06 30
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 03 19
最終更新日/Last modified on
2019 09 20


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000036286
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036286

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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