Morbidly Adherent PlacentaNCT03976453

Psychological Outcome of Women With Morbidly Adherent Placenta Following Hystrectomy

An observational study of Morbidly Adherent Placenta, run by Ain Shams Maternity Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the risk of postoperative psychiatric disorders of depression, anxiety outcomes and sexual dysfunctions and self esteem disturbance in women with morbidly adherent placenta following hysterectomy. Read more about this study

Who is it for?: Ages Up to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Morbidly Adherent Placenta
How many people: 120 participants
Where: 1 siteEgypt
Study dates: 15 Jun 2019to 30 Mar 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 Up to 45 years
Women only
Healthy volunteers accepted
Child, Adult

Study population: Females in child bearing period presented with morbidly adherent placenta

Who may be able to join

The 3 groups should be matched in age and parity. Age of child bearing period. Women who delivered from 4-6 months ago. At a gestational age after age of viability (28 weeks).

Who cannot join

Pre-existing psychological disorders.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams University Maternity Hospital
Cairo

Other trials in Egypt

About this study

Official title: Psychological Outcome of Women With Morbidly Adherent Placenta Following Hystrectomy: Prospective Matched Case-control Study

Research hypothesis:

In women with morbidly adherent placenta, We will predict, evaluate and decrease the psychological disorders following hysterectomy.

Research question:

Is there any difference in psychological outcome between caesarean section and caesarean hysterectomy ? This study aims to assess the psychological outcome in women with morbidly adherent placenta following hysterectomy.

Read the detailed description

Morbidly adherent placenta, which describes placenta accreta, increta, and percreta, implies an abnormal implantation of the placenta into the uterine wall.

The incidence of placenta accreta has increased significantly over the past several decades, with the main risk factors include prior cesarean section and placental previa.

However, no well-designed trials have yet assessed the psychological outcome of women with morbidly adherent placenta following hystrectomy. The investigators will conduct a prospective matched case control trial to evaluate the psychological outcome to assess the risk of depression ,anxiety , sexual dysfunctions and self esteem disturbance following hysterectomy in women with morbidly adherent placenta.

This Prospective matched case-control trial will take place at Ain Shams University Maternity Hospital. Women in child bearing period, with morbidly adherent placenta will be eligible for inclusion.

Placenta accreta (Morbidly adherent placenta) is a condition in which all or part of the placenta is adherent to the uterine wall because of myometrial invasion by chorionic villi. It may occur when there is either a primary deficiency of or a secondary damage to chorionic villi or Nitabuch's layer.

Morbidly adherent placenta occurs in 5% of women with placenta previa. In some pregnancies, the placenta may develop at an abnormal location or may extensively invade the adjacent myometrium. Clinical entities include placenta previa, in which trophoblastic cells implant over or near the internal cervical os .In other cases, trophoblast aggressively burrows into the myometrium. Depending on the invasion depth, placenta accreta, placenta increta, or placenta percreta is diagnosed. The term placenta accrete syndromes is clinically useful to summarize these three types. Another interchangeable phrase also often used is morbidly adherent placenta .

Assisted reproductive technology and maternal smoking increase the risk of placenta.

The risk of accrete in women with a placenta previa and a prior caesarean section increased from 3% with one previous caesarean section to 11%, 40%, 61% and 67% with two, three, four, or more repeat caesarean sections respectively .

The maternal mortality risk may reach 7 % and the extensive surgery related morbidities include massive transfusions, infections, urologic injuries and fistula formation .

Women often consider the uterus to be a sexual organ, and the controller and regulator of important physiological functions in the body, as well as the source of youth, energy, activity, and a symbol of child-bearing capacity .

The relationship between hysterectomies and psychological disorders has been raised since the beginning of the 1990s. For example, in 1997, Thompson reported that there was a probability of psychoses in women after hysterectomies; and within the three years following the surgery, 33% of the women experienced symptoms of depression .

There are three broad subsets of psychological symptoms. These are: anxiety and depression attributed to the operation, sexual dysfunction (presenting as diminished libido, pain, dyspareunia or anxiety surrounding sexual activity) and reactions related to perceptions of feminity and low self-esteem.

Conditions: Morbidly Adherent Placenta
Medical subject headings: Placenta Accreta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03976453
Study group	Role	What they receive
Group A		Women who underwent caesarean hysterectomy
Group B		Women who underwent lower segment caesarean section
Group C		Women who underwent spontaneous Vaginal delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through SCID I .Structured Clinical Interview for DSM-IV (SCID I) is a flexible semi structured diagnostic interview designed for use by trained clinicians to diagnose many adult DSM-IV axis I clinical disorders. It includes 7 diagnostic modules, focused on different diagnostic groups: mood, psychotic, substance abuse, anxiety, somatoform, eating and adjustment disorders then using Beck depression inventory scale.This is an inventory used for assessing the severity of depression state. It consists of 21 items, each of which has four responses of increasing severity. Numerical values from 0-3 are assigned each statement to indicate the degree of severity. The Arabic version will be used for the study.
Measured: Baseline
Sexual dysfunction
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through a a test which is a brief questionnaire measure of sexual functioning in women. It is 19-item questionnaire has been developed as a multidimensional self-report instrument for assessing the key dimensions of sexual function in women. It provides scores on six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction and pain) as well as a total score. The FSFI total score varies between 1.2 and 36, a score ≤ 26 defines sexual dysfunction. It is not a measure of sexual experience, knowledge, attitude, or interpersonal functioning in women. The Arabic version used in this research was a validated, reliable, and locally accepted tool for use in the assessment of female sexual disorder in the Egyptian population .
Measured: Baseline
Anxiety
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through Taylor scale. It is performed to assess the anxiety state. This early instrument is derived from the MMPI in which the patient has to answer Yes or No to these questions, which are phrased in formal Arabic and can be understood by all those people who can read simple Arabic.
Measured: Baseline
Self-esteem disturbance
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research. The self esteem scale is an Arabic self reported questionnaire designed to assess the overall self esteem of the reporter. It measures the self view of the reporter to his capabilities in different situations, for example: social situations, interpersonal relations, future ambitions and previous accomplishments.
It is composed of 30 items rated as follows: frequently = 2, sometimes = 1 and never = 0. Items indicating low self esteem are inversely scored. Scoring is done by summing the ordinary questions and inversely scored questions. Higher scores indicate higher self esteem.
The instrument showed good internal consistency reliability (0.76). The construct convenient of the scale is fairly supported by factor analysis and convergent validation with other scales measuring self esteem
Measured: Baseline

Secondary outcomes (1)

Any other possible psychiatric morbidity
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through SCID I .Structured Clinical Interview for DSM-IV (SCID I) is a flexible semi structured diagnostic interview designed for use by trained clinicians to diagnose many adult DSM-IV axis I clinical disorders. It includes 7 diagnostic modules, focused on different diagnostic groups: mood, psychotic, substance abuse, anxiety, somatoform, eating and adjustment disorders. The Arabic version of the structured clinical interview for DSM-IV axis I (SCID-I) will be used in this study.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201930 Mar 2020

First posted6 Jun 2019
Study start15 Jun 2019
Primary completion30 Aug 2019
Study completion30 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Morbidly Adherent PlacentaStudies 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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03976453
Sponsor's protocol ID: Morbidly Adherent Placenta
Status last verified: Jan 2021
First submitted: 31 May 2019
Last updated: 12 Jan 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All data resulting from this study will be published

Publications

Anis TH, Gheit SA, Saied HS, Al kherbash SA. Arabic translation of Female Sexual Function Index and validation in an Egyptian population. J Sex Med. 2011 Dec;8(12):3370-8. doi: 10.1111/j.1743-6109.2011.02471.x. Epub 2011 Oct 13.
PubMed 21995610
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369
Broome A and Wallace L, eds. (1984): Psychology and Gynecological Problems. Tavistock Publications, London.
Cunningham FG, Leveno KJ, Bloom SL, et al. (eds) (2014): Obstetrical hemorrhage. In: Williams Obstetrics, 24th ed. New York, McGraw-Hill Education, pp: 505-511
Cunningham FG, MacDonald PC, Gant NF et al. (eds) (1997): Obstetrical haemorrhage. In: Williams Obstetrics, 20th ed. Appleton& Lange: Stanford, CT, pp: 755-6.
El Missiry A (2003): Homicide and psychiatric illness, An Egyptian study. MD Thesis, Faculty of Medicine, Ain Shams University.
First MB, Spitzer RL and Williams W (1995): Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) in Handbook of Psychiatric Measures. Washington, American Psychiatric Association.
Gielchinsky Y, Mankuta D, Rojansky N, Laufer N, Gielchinsky I, Ezra Y. Perinatal outcome of pregnancies complicated by placenta accreta. Obstet Gynecol. 2004 Sep;104(3):527-30. doi: 10.1097/01.AOG.0000136084.92846.95.
PubMed 15339763
Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
PubMed 30260097
O'Brien JM, Barton JR, Donaldson ES. The management of placenta percreta: conservative and operative strategies. Am J Obstet Gynecol. 1996 Dec;175(6):1632-8. doi: 10.1016/s0002-9378(96)70117-5.
PubMed 8987952
Rahimzadeh A and Nazemi AR (2002): A Survey About the Effect Of Hysterectomy on Sexual Dysfunction in Patients Underwent Surgery in Sanandaj Behsat Hospital. Sci J Kurdistan Univ Med Sci; 2(3): 50-55.
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451
Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
PubMed 16738145
TAYLOR JA. A personality scale of manifest anxiety. J Abnorm Psychol. 1953 Apr;48(2):285-90. doi: 10.1037/h0056264. No abstract available.
PubMed 13052352
Alipour A and Pour Y (2010): Effect of cognitive behavioral therapy in hastening recovery of women after hysterectomy surgery. J Behav Sci; 4(2):91-5

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Psychological Outcome of Women With Morbidly Adherent Placenta Following Hystrectomy: Prospective Matched Case-control Study
ClinicalTrials.gov ID: NCT03976453
Acronym / sponsor ID: Morbidly Adherent Placenta
Conditions: Morbidly Adherent Placenta
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Ain Shams Maternity HospitalUniversity, hospital or other
Study start: 15 Jun 2019 (actual)
Primary completion: 30 Aug 2019 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 6 Jun 2019 (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.

Research hypothesis:

In women with morbidly adherent placenta, We will predict, evaluate and decrease the psychological disorders following hysterectomy.

Research question:

Detailed description

Morbidly adherent placenta, which describes placenta accreta, increta, and percreta, implies an abnormal implantation of the placenta into the uterine wall.

The incidence of placenta accreta has increased significantly over the past several decades, with the main risk factors include prior cesarean section and placental previa.

This Prospective matched case-control trial will take place at Ain Shams University Maternity Hospital. Women in child bearing period, with morbidly adherent placenta will be eligible for inclusion.

Assisted reproductive technology and maternal smoking increase the risk of placenta.

The maternal mortality risk may reach 7 % and the extensive surgery related morbidities include massive transfusions, infections, urologic injuries and fistula formation .

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Group A	–	–Women who underwent caesarean hysterectomy
Group B	–	–Women who underwent lower segment caesarean section
Group C	–	–Women who underwent spontaneous Vaginal delivery

Who may qualify

Ages: Up to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Females in child bearing period presented with morbidly adherent placenta

Key inclusion criteria (1 listed)

The 3 groups should be matched in age and parity. Age of child bearing period. Women who delivered from 4-6 months ago. At a gestational age after age of viability (28 weeks).

Key exclusion criteria (1 listed)

Pre-existing psychological disorders.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Depression
Time frame: Baseline
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through SCID I .Structured Clinical Interview for DSM-IV (SCID I) is a flexible semi structured diagnostic interview designed for use by trained clinicians to diagnose many adult DSM-IV axis I clinical disorders. It includes 7 diagnostic modules, focused on different diagnostic groups: mood, psychotic, substance abuse, anxiety, somatoform, eating and adjustment disorders then using Beck depression inventory scale.This is an inventory used for assessing the severity of depression state. It consists of 21 items, each of which has four responses of increasing severity. Numerical values from 0-3 are assigned each statement to indicate the degree of severity. The Arabic version will be used for the study.
Sexual dysfunction
Time frame: Baseline
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through a a test which is a brief questionnaire measure of sexual functioning in women. It is 19-item questionnaire has been developed as a multidimensional self-report instrument for assessing the key dimensions of sexual function in women. It provides scores on six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction and pain) as well as a total score. The FSFI total score varies between 1.2 and 36, a score ≤ 26 defines sexual dysfunction. It is not a measure of sexual experience, knowledge, attitude, or interpersonal functioning in women. The Arabic version used in this research was a validated, reliable, and locally accepted tool for use in the assessment of female sexual disorder in the Egyptian population .
Anxiety
Time frame: Baseline
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through Taylor scale. It is performed to assess the anxiety state. This early instrument is derived from the MMPI in which the patient has to answer Yes or No to these questions, which are phrased in formal Arabic and can be understood by all those people who can read simple Arabic.
Self-esteem disturbance
Time frame: Baseline
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research. The self esteem scale is an Arabic self reported questionnaire designed to assess the overall self esteem of the reporter. It measures the self view of the reporter to his capabilities in different situations, for example: social situations, interpersonal relations, future ambitions and previous accomplishments. It is composed of 30 items rated as follows: frequently = 2, sometimes = 1 and never = 0. Items indicating low self esteem are inversely scored. Scoring is done by summing the ordinary questions and inversely scored questions. Higher scores indicate higher self esteem. The instrument showed good internal consistency reliability (0.76). The construct convenient of the scale is fairly supported by factor analysis and convergent validation with other scales measuring self esteem

1 secondary outcome

Any other possible psychiatric morbidity
Time frame: Baseline

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 12 Jan 2021.
Background: PubMed 21995610Anis TH, Gheit SA, Saied HS, Al kherbash SA. Arabic translation of Female Sexual Function Index and validation in an Egyptian population. J Sex Med. 2011 Dec;8(12):3370-8. doi: 10.1111/j.1743-6109.2011.02471.x. Epub 2011 Oct 13.
Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
BackgroundBroome A and Wallace L, eds. (1984): Psychology and Gynecological Problems. Tavistock Publications, London.
BackgroundCunningham FG, Leveno KJ, Bloom SL, et al. (eds) (2014): Obstetrical hemorrhage. In: Williams Obstetrics, 24th ed. New York, McGraw-Hill Education, pp: 505-511
BackgroundCunningham FG, MacDonald PC, Gant NF et al. (eds) (1997): Obstetrical haemorrhage. In: Williams Obstetrics, 20th ed. Appleton& Lange: Stanford, CT, pp: 755-6.
BackgroundEl Missiry A (2003): Homicide and psychiatric illness, An Egyptian study. MD Thesis, Faculty of Medicine, Ain Shams University.
BackgroundFirst MB, Spitzer RL and Williams W (1995): Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) in Handbook of Psychiatric Measures. Washington, American Psychiatric Association.
Background: PubMed 15339763Gielchinsky Y, Mankuta D, Rojansky N, Laufer N, Gielchinsky I, Ezra Y. Perinatal outcome of pregnancies complicated by placenta accreta. Obstet Gynecol. 2004 Sep;104(3):527-30. doi: 10.1097/01.AOG.0000136084.92846.95.
Background: PubMed 30260097Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
Background: PubMed 8987952O'Brien JM, Barton JR, Donaldson ES. The management of placenta percreta: conservative and operative strategies. Am J Obstet Gynecol. 1996 Dec;175(6):1632-8. doi: 10.1016/s0002-9378(96)70117-5.
BackgroundRahimzadeh A and Nazemi AR (2002): A Survey About the Effect Of Hysterectomy on Sexual Dysfunction in Patients Underwent Surgery in Sanandaj Behsat Hospital. Sci J Kurdistan Univ Med Sci; 2(3): 50-55.
Background: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Individual participant dataSharing planned: Yes. All data resulting from this study will be published

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.

Amr El Shalakany, Prof principal investigator

Ain Shams Maternity 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 Morbidly Adherent Placenta, run by Ain Shams Maternity Hospital 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 12 Jan 2021. 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?

Depression (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03976453, which also lists 15 linked publications.

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 12 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.