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IRCT20170506033834N12 IRCT 2024-02-12 Tabriz University of Medical Sciences Design and implementation of interventions to improve unplanned pregnancy experiences Design and implementation of interventions to improve unplanned pregnancy experiences 2024-06-21 anticipated 60 Complete https://irct.ir/trial/74839 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is in line with the policy of having children and improving unplanned pregnancy experiences and reducing elective abortions, Randomization description: In order to assign the participants to the study groups, using the random block method, allocated according to the type of unplanned pregnancy (unwanted or untimely) It will be used with the size of blocks of 4 and 6 and with an allocation ratio of 1:1. For Allocation Concealment, the type of intervention is written on paper and inside matte envelopes on the back of the head. It will also be numbered. Then, the related envelope will be determined by a person not involved in open sampling and the type of intervention received. N/A pregnancy. Intervention 1: Intervention group:The target population will be women aged 18 to 45 with an unplanned pregnancy who refer to Tabriz city health centers for prenatal care in 1403. In this step, sampling of mothers eligible to participate in the present study will be done using the available method, then Full explanations about the research, its goals and the method of its implementation will be given to the women. In case of desire to participate in the study, written informed consent will be obtained from the women and The participants will be provided with sufficient assurance regarding the confidentiality of the information obtained. , the violence and attachment of the mother to the fetus will be completed. In this study, pregnancy experience will be measured as the primary outcome and depression, anxiety, violence and attachment of the mother to the fetus and premature birth will be measured as secondary outcomes. In order to assign the participants to the study groups, using the random block method, allocated according to the type of unplanned pregnancy (unwanted or untimely) It will be used with the size of blocks of 4 and 6 and with an allocation ratio of 1:1. For Allocation Concealment, the type of intervention is written on paper and inside matte envelopes on the back of the head. It will also be numbered. Then the related envelope will be determined by a person not involved in open sampling and the type of intervention received. The type of intervention applied in the intervention group will be determined after reviewing the literature and qualitative study and holding an expert panel. Intervention 2: Control group: No intervention will be applied in the control group and only routine prenatal care will be given. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Masoumeh Paiandeh
Faculty of Nursing and Midwifery, South Shariati, Tabriz
Tabriz Iran (Islamic Republic of) 5313644351 +98 41 6770 3479 m_paiande@yahoo.com Tabriz University of Medical Sciences scientific Dr. Roghaiyeh Nourizadeh
Faculty of Nursing and Midwifery, South Shariati, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3477 0648 nourizadehr@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women with unplanned pregnancies Mother's age is 18-45 years singleton pregnancy Live fetus 18 years 45 years Female Vaginal bleeding (threat of miscarriage) Previous history of depression according to mother's statement Having maternal or fetal indications for termination of pregnancy Disagreement with the wife according to mother's statement Other Other Intervention group:The target population will be women aged 18 to 45 with an unplanned pregnancy who refer to Tabriz city health centers for prenatal care in 1403. In this step, sampling of mothers eligible to participate in the present study will be done using the available method, then Full explanations about the research, its goals and the method of its implementation will be given to the women. In case of desire to participate in the study, written informed consent will be obtained from the women and The participants will be provided with sufficient assurance regarding the confidentiality of the information obtained. , the violence and attachment of the mother to the fetus will be completed. In this study, pregnancy experience will be measured as the primary outcome and depression, anxiety, violence and attachment of the mother to the fetus and premature birth will be measured as secondary outcomes. In order to assign the participants to the study groups, using the random block method, allocated according to the type of unplanned pregnancy (unwanted or untimely) It will be used with the size of blocks of 4 and 6 and with an allocation ratio of 1:1. For Allocation Concealment, the type of intervention is written on paper and inside matte envelopes on the back of the head. It will also be numbered. Then the related envelope will be determined by a person not involved in open sampling and the type of intervention received. The type of intervention applied in the intervention group will be determined after reviewing the literature and qualitative study and holding an expert panel. Control group: No intervention will be applied in the control group and only routine prenatal care will be given. Pregnancy experiences. Timepoint: before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy with control of the baseline effect. Method of measurement: PES (Pregnancy Experience Scale) Questionnaire. Mother's anxiety. Timepoint: before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy by controlling the effect of the baseline score. Method of measurement: PRAQ (Pregnancy-Related Anxiety Questionnaire). Depression. Timepoint: before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy by controlling the effect of the baseline score. Method of measurement: Edinburgh's Depression During Pregnancy Tool. Perceived maternal violence. Timepoint: before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy with control of the baseline effect. Method of measurement: 4-item tool HITS (Hurts, Insults, Threaten, Screams). Mother's attachment to the fetus. Timepoint: before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy with control of the baseline effect. Method of measurement: Cranley's mother-fetus attachment questionnaire. Preterm delivery. Timepoint: Frequency of preterm delivery with effect adjustment of baseline values. Method of measurement: Baby care card. Tabriz University of Medical Sciences Approved 2024-01-06 Ethics Committee of Tabriz University of Medical Sciences Golgasht St., Tabriz University of Medical Sciences, Faculity of Dentistry Tabriz East Azarbaijan Iran (Islamic Republic of)