Clinical trial NCT03976453: Psychological Outcome of Women With Morbidly Adherent Placenta Following Hystrectomy
Official title: Psychological Outcome of Women With Morbidly Adherent Placenta Following Hystrectomy: Prospective Matched Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbidly Adherent Placenta
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 120
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females in child bearing period presented with morbidly adherent placenta

Brief 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

- 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).

Exclusion Criteria:

- Pre-existing psychological disorders.

Primary outcomes:
measure: Depression
timeFrame: Baseline
measure: Sexual dysfunction
timeFrame: Baseline
measure: Anxiety
timeFrame: Baseline
measure: Self-esteem disturbance
timeFrame: Baseline
Secondary outcomes:
measure: Any other possible psychiatric morbidity
timeFrame: Baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Amr El Shalakany, Prof
role: PRINCIPAL_INVESTIGATOR
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