Placenta Previa TotalNCT04274062
Effects of Peri Partum Integrated Nursing Care Versus Routine Care in Placenta Previa : A Randomized Controlled Trail
An observational study of Placenta Previa Total and Nursing Role, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
At our institution, the annual number of placenta previa was 494 cases (1.7%); of whom 95 cases (19.2%) were proved to have a placenta accreta. Perioperatively, they are subjected to regular care of a tertiary university hospital. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Previa Total, Nursing Role
- What is being tested?
- Integrated Nursing care of placenta previa
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 2 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant Placenta previa
Who may be able to join
- Pregnant women with diagnosis of placenta previa.
Who cannot join
- Other high risk pregnancy cases
Trial locations and contacts
1 site in 1 country.
About this study
At our institution, the annual number of placenta previa was 494 cases (1.7%); of whom 95 cases (19.2%) were proved to have a placenta accreta. Perioperatively, they are subjected to regular care of a tertiary university hospital. This study aims to determine the effectiveness of peri partum integrated nursing care for the patients with placenta previa versus routine care.
Read the detailed description
Study design:
Experimental design: (randomized control trail)
Setting:
This study will be conducted at Woman's Health Hospital, Assiut University, emergency department and inpatient department.
Sample:
A convenience sample will be used, the total sample will include (100) patients with placenta previa, divided into two group1:1
- group 1: 50 patients study group
- group2: 50 patients control group
- Conditions
- Placenta Previa Total, Nursing Role
- Being tested
- Integrated Nursing care of placenta previa
- Keywords
- placenta previa, Nursing, antepartum hemorrhage, randomized trial
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Nursing care of placenta previaProcedure or surgery
Phase I :( preparation phase) Phase II: (Implementation phase) includes Preoperative care , intraoperative care and postoperative care by a nurse.
Phase III: (Evaluation phase)
| Study group | Role | What they receive |
|---|---|---|
| peri partum integrated nursing care of placenta previa | * Part (1) personal data:
* Part (2) baseline and characteristics of the patients participants:
* Tool II- An observation checklist: This tool is develop by researcher according to guideline of Royal College of Obstetricians and Gynaecologists, 2018), and divide into three main parts: preoperative, intraoperative and postoperative.
* Part (1) pre-operative: includes assessment of :
* patients general condition
* investigation
* reserved blood
* Hemoglobin level
* Impact of hysterectomy option. -9-
Part (2) Intra-operative:
Includes assessment of :-
* Investigation
* Vital signs
* Hypothermia
* Blood loss
* I.V fluid
* Blood gases
* Fetal condition and APGAR score.
* Part (3) Post-operative: Includes:
* maternal complication
* fetal complication
* psychological satisfaction Receives: Procedure: Integrated Nursing care of placenta previa | |
| peri partum regular care of placenta previa | Routine nursing care of all cases of placenta previa (preoperative, intraoperative and postoperative).. Receives: Procedure: Integrated Nursing care of placenta previa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved maternal and fetal well beings in cases of placenta previa
Adding an integrated nursing care to the regular care of cases of placenta previa
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 May 2019
- Primary completion1 Nov 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Previa TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
- Investigators
- Atef Darwish, Principal investigator, Woman's Health University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274062
- Sponsor's protocol ID
- Randomized controlled trial
- Status last verified
- Dec 2020
- First submitted
- 12 Feb 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peri Partum Integrated Nursing Care Versus Routine Care in Placenta Previa : A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT04274062
- Acronym / sponsor ID
- Randomized controlled trial
- Conditions
- Placenta Previa Total, Nursing Role
- Keywords
- placenta previa, Nursing, antepartum hemorrhage, randomized trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At our institution, the annual number of placenta previa was 494 cases (1.7%); of whom 95 cases (19.2%) were proved to have a placenta accreta. Perioperatively, they are subjected to regular care of a tertiary university hospital. This study aims to determine the effectiveness of peri partum integrated nursing care for the patients with placenta previa versus routine care.
Detailed description
Study design:
Experimental design: (randomized control trail)
Setting:
This study will be conducted at Woman's Health Hospital, Assiut University, emergency department and inpatient department.
Sample:
A convenience sample will be used, the total sample will include (100) patients with placenta previa, divided into two group1:1
- group 1: 50 patients study group
- group2: 50 patients control group
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peri partum integrated nursing care of placenta previa | – | Procedure: Integrated Nursing care of placenta previa* Part (1) personal data: * Part (2) baseline and characteristics of the patients participants: * Tool II- An observation checklist: This tool is develop by researcher according to guideline of Royal College of Obstetricians and Gynaecologists, 2018), and divide into three main parts: preoperative, intraoperative and postoperative. * Part (1) pre-operative: includes assessment of : * patients general condition * investigation * reserved blood * Hemoglobin level * Impact of hysterectomy option. -9- Part (2) Intra-operative: Includes assessment of :- * Investigation * Vital signs * Hypothermia * Blood loss * I.V fluid * Blood gases * Fetal condition and APGAR score. * Part (3) Post-operative: Includes: * maternal complication * fetal complication * psychological satisfaction |
| peri partum regular care of placenta previa | – | Procedure: Integrated Nursing care of placenta previaRoutine nursing care of all cases of placenta previa (preoperative, intraoperative and postoperative).. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant Placenta previa
Key inclusion criteria (1 listed)
- Pregnant women with diagnosis of placenta previa.
Key exclusion criteria (1 listed)
- Other high risk pregnancy cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Nursing care of placenta previaPhase I :( preparation phase) Phase II: (Implementation phase) includes Preoperative care , intraoperative care and postoperative care by a nurse. Phase III: (Evaluation phase) | Procedure or surgery | peri partum integrated nursing care of placenta previa, peri partum regular care of placenta previa |
Primary outcome
Improved maternal and fetal well beings in cases of placenta previa
Time frame: 2 years
Adding an integrated nursing care to the regular care of cases of placenta previa
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atef Darwish principal investigator
Woman's Health University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa Total and Nursing Role, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved maternal and fetal well beings in cases of placenta previa (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.